Manufacturing & Production

Amgen

Process Analytical Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**ProcessAnalyticalEngineer**

**What youwill do**

In this vital role, you will join the Facilities & Engineering (F&E) group andbe responsible forplanning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands-on troubleshooting and root cause analysis for analytical and laboratory systems, coordination of vendor support and repairs, execution and tracking of calibration, maintenance, and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo, and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author, own, and approve Validation Life Cycle documents for computer-related systems, including responsibility for Data Integrity testing and business administration of laboratory computer-related systems.

- Support commissioning, qualification, validation, and system lifecycle documentation tomaintaincompliance and operational readiness.

- Partner closely with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.

**Key responsibilities:**

- **System ownership, reliability, and operations**

- Work with the capital project team to ensure systems are installed andoperatesafely,comply withpertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements.

- Serve asSystemOwner and Business Administrator foranalyticalequipment.

- Lead or work with teams in design, development andselectionof new systems, instruments, calibrationcapabilitiesand consumable components.

- Development of laboratory equipment specifications touse for procurement of new laboratory equipment and instruments.

- Maintaining a current working knowledgeregardingregulatory requirements for equipment qualification and calibration.

- Support in generation and resolution of protocol discrepancies asrequired.

- Alerting Quality Control Management if equipmentfails tomeet calibration or qualification requirements and conducting impact assessments/investigations asrequired.

- Lead the development of calibration/maintenance programs, ensure the availability of spare parts, schedule repairs and maintenance, and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities.

- Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.

- Evaluatethe capabilitiesof current and potential suppliers, and assessnew technologiesthat could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.

- Writing/contributing to equipment operating procedures and manuals.

- Designing and conducting training formanufacturingstaff, and other department staff as applicable.

- Own and project manage change controls while meeting applicable change control metrics.

- Preparing and presenting periodic management updates on activities to senior management.

- Conduct periodic reviews of instrument validation as part of validation life cycle.

- **Validation, compliance, and quality systems**

- A key contributor to Data Integrity Assessments for Lab systems

- Support Amgens laboratory systems validation and Data Integrity philosophy during audit interactions.

- Supportadditionaltasks andprojects asassigned by management.

- **Cross-functional support, projects, and continuous improvement**

- Develop, coordinate, analyze, and present results for operational issues and engineering projects

- Provide technical supportforcommercial and clinical manufacturing as needed.

- Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.

- Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.

- Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and support interactions with regulatoryinspectorsas necessary.

- Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.

- Monitor systems toidentifyperformance risks and implement risk reduction strategies.

- Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation ofcorrective/preventive action; support may berequiredoutside of normal working hours, including nights, weekends, and holidays.

- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

- Advance the use of condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable.

- Lead investigations of abnormal conditions through Deviation and related business processes.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

- Masters degree

OR

- Bachelors degree and2years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

OR

- Associates degree and6years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

OR

- High school diploma / GED and8years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

**Preferred Qualifications:**

- Bachelors degree in engineering or related technical field

- Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.

- Knowledge of themethodologyand instrumentation and analytical techniques used for biopharmaceutical testing.

- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

- Demonstrated success in managing an equipment qualification or maintenance program.

- Ability to provide On-Callsupportcoveragenights and weekends, on a rotating basis.

- Position requires strong written and verbal skills and the ability to work withminimumdirection.

- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.

- Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.

- Ability to function within cross-functional teams and embrace a team-based environment.

- Work schedule flexibility asrequiredto support 24/7 operations.

- Ability for domestic/international travel.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

**Apply now and make a lasting impact with the Amgen team!**

**careers.amgen.com**

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

North Carolina

Senior Manufacturing Systems Engineer - PLC Systems

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**SeniorManufacturing Systems EngineerPLC**

**What youwill do**

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and supportofPLC based processesand utility skid equipmentautomation needs.You will solve complex engineering problems and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, andqualifynew equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing on manufacturing automation.

Job responsibilities include:

**Site design, construction, start-up, and operational readiness:**

- Provide support to the capital project team with a strong focus on safety and on-time facility start-up.

- Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutionsforPLC basedsystems.

- Work withplatformleads to ensure standalone PLC based systems are designed withthe propernetwork connectivityandsystem-to-system communicationto enable centralized monitoring and alarming.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).

- Partner with various organizational units to support tasks including operational readiness, document reviews, deviationinvestigationand change controls.

- Develop andmaintaindetailed specifications,SOPsand operating standards thatimpactmultiple organizational units.

- Provide mentoring to develop and accelerate site technical automation capabilities.

**Site Operations:**

- Act as system owner for standalone PLC based systems.

- Manage Day-to-day Operational Support including:24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,preventive and corrective maintenance, system administration, andAutomation Systemspare parts management

- Lead and support functional area projects focused on improvingequipment/utilities/facilitiesas well as capital projects to integrate new drug substance manufacturing technologies into the facility.

- Lead and support technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.

- Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchangesand supporting engineering and process qualification runs as applicable.

- Prepare and review Standard Operating Procedures (SOP) and cGMP documents.

- On-site and up to 10%domestic/international travel

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and 10 years of Engineering experience OR
- Associates Degree and 8 years of Engineering experience OR
- Bachelors Degree and 4 years of Engineering experience OR
- Masters Degree and 2 years of Engineering experience OR
- Doctorate Degree

**Preferred Qualifications:**

- Degree in Electrical Engineering or Computer Science, ChemicalEngineeringorBiotech Engineering.

- Extensive experience withprocess and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologiessuch as Rockwellplatforms.

- Direct knowledge of integrating various OEM automation software and field instrumentation technologies.

- Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.

- Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies.

- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.

- In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.

- Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.

- The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

- Strong leadership, technical writing, and communication/presentation skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

**Apply now and make a lasting impact with the Amgen team!**

**careers.amgen.com**

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Manufacturing Systems Engineer DeltaV

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**SeniorManufacturingSystemsEngineer DeltaV**

**What youwill do**

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, and drive innovation and support manufacturings upstream, downstream, and solution preparation automation needs.You will solve complex engineering problems and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, andqualifynew equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing on manufacturing automation.

Job responsibilities include:

- **Site design, construction, start-up, and operational readiness:**

- Provide support to the capital project team with a strong focus on safety and on-time facility start-up.

- Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarilyutilizingEmersonDeltaVDistributed Control System (DCS) forupstream, downstream, and/or solution prepoperations.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).

- Partner with various organizational units to support tasksincluding operational readiness, document reviews, deviationinvestigationand change controls.

- Develop andmaintaindetailed specifications,SOPsand operating standards thatimpactmultiple organizational units.

- Provide mentoring to develop and accelerate site technical automation capabilities.

- **Site Operations:**

- Act as system owner forUpstream,Downstream, and/or Solution prepAutomation processes.

- Manage Day-to-day Operational Support including:24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, andAutomation Systemspare parts management

- Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as capital projects to integrate new drug substance manufacturing technologies into the facility.

- Lead and support technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.

- Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchangesand supporting engineering and process qualification runs as applicable.

- Prepare and review Standard Operating Procedures (SOP) and cGMP documents.

- On-site roleand up to 10% domestic/international travel

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and 10 years of Engineering experience OR
- Associates Degree and 8 years of Engineering experience OR
- Bachelors Degree and 4 years of Engineering experience OR
- Masters Degree and 2 years of Engineering experience OR
- Doctorate Degree

**Preferred Qualifications:**

- Degree in Electrical Engineering or Computer Science, ChemicalEngineeringorBiotech Engineering.

- Extensive experience with EmersonDeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.

- Direct knowledge of integrating various OEM automation software and field instrumentation technologies.

- Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.

- Experiencewith upstream/downstream/solution prepunit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/diafiltrationamong others.

- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.

- In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.

- Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.

- The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

- Strong leadership, technical writing, and communication/presentation skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

**Apply now and make a lasting impact with the Amgen team!**

**careers.amgen.com**

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Manager, Instructional Design and Labeling Operations

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Manager, Instructional Design and Labeling Operations**

**What you will do**

Lets do this. Lets change the world. The Senior Manager, Instructional Design and Labeling Operations will lead the Instructional Design team within Customer Experience and Design, supporting the development, lifecycle management, review, and operational execution of Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork deliverables for combination products and other regulated medical products.

This role is first and foremost a people leadership and operational excellence role. The Senior Manager will lead a mixed team of Amgen employees and external workers, build team capability, strengthen career development, manage capacity and priorities, and mature the Instructional Design and Labeling Operations function. The role will also own the process governance, implementation, adherence, and continuous improvement of SOP-437076, ensuring that Instructional Design workflows are clear, scalable, compliant, and effectively integrated into cross-functional product development and submission activities.

The successful candidate does not need to be a formal instructional designer. However, they must bring strong people leadership, process ownership, stakeholder management, and regulated medical product experience, with the ability to lead teams working across labeling, artwork, Human Factors study support, source text alignment, documentation, review cycles, vendor coordination, and Health Authority submission readiness.

This leader will partner closely with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Final Product Teams, Quality, vendors, and other cross-functional stakeholders to ensure deliverables are completed with quality, traceability, usability, compliance, and business impact.

**Key Responsibilities:**

**People Leadership and Team Development**

- Lead, coach, and develop a team of Instructional Design Engineers
- Serve as a career development champion by clarifying role expectations, supporting development plans, creating growth opportunities, and helping team members build differentiated career paths.
- Build a high-performing team culture grounded in accountability, collaboration, learning, quality, operational discipline, and customer focus.
- Manage team priorities, workload, capacity, onboarding, performance, development, and resource allocation.
- Provide effective oversight of external workers and/or contractors, including onboarding, work assignment, deliverable expectations, execution quality, and integration into team workflows.
- Help the team navigate ambiguity, competing priorities, cross-functional dependencies, and escalation needs.

**Functional Leadership and Operating Model**

- Lead the Instructional Design and Labeling Operations function within Customer Experience and Design.
- Translate portfolio needs, Human Factors milestones, labeling deliverables, study timelines, submission needs, and business priorities into executable team plans.
- Establish mechanisms to monitor workload, workflow health, quality trends, cycle times, risks, rework drivers, and delivery commitments.
- Strengthen the operating model for Instructional Design and Labeling Operations, including role clarity, decision rights, intake, prioritization, escalation, metrics, and cross-functional handoffs.
- Ensure the teams work supports broader Customer Experience objectives, including improved patient learning materials, usability, complaint reduction, and customer experience outcomes.

**SOP Ownership and Process Improvement**

- Lead process improvement efforts across the IFU / NAF lifecycle, including NAF strategy, creation, revision, review cycles, Human Factors study support, source text alignment, submission support, vendor coordination, and launch readiness activities.
- Develop, maintain, and improve supporting tools such as templates, checklists, standards, process maps, training materials, metrics, and review expectations.
- Identify and resolve process gaps, handoff inefficiencies, documentation risks, role clarity issues, recurring workflow pain points, and compliance vulnerabilities.
- Champion scalable and compliant ways of working that improve predictability, audit readiness, quality, speed of execution, and team sustainability.

**Instructional Design, Labeling Operations, and Regulated Artwork Oversight**

- Provide leadership oversight for development and revision of IFUs, instructional artwork, illustrations, NAFs, study stimuli, and related deliverables used to support development activities, Human Factors studies, Health Authority interactions, and product commercialization.
- Ensure Instructional Design deliverables are developed and maintained with appropriate attention to user needs, usability principles, labeling requirements, regulatory expectations, documentation traceability, and quality standards.
- Oversee activities related to NAF strategy, artwork creation, review cycles, source text alignment, print readiness, study stimuli preparation, vendor coordination, and submission readiness.
- Ensure appropriate quality checks, review discipline, documentation, and inspection practices are in place before deliverables progress to formal review, study use, or submission.
- Support issue resolution and decision-making when design, usability, labeling, regulatory, packaging, artwork, quality, or operational considerations conflict.

**Cross-Functional Collaboration and Vendor Management**

- Build strong partnerships with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Quality, Final Product Teams, vendors, and other partners.
- Represent Instructional Design and Labeling Operations in portfolio, program, governance, and process discussions where team commitments, risks, vendor performance, or functional strategy are impacted.
- Communicate priorities, risks, decisions, and tradeoffs clearly to senior leaders and cross-functional stakeholders.
- Influence across matrix teams to drive alignment, remove barriers, and maintain momentum.
- Manage vendor and contractor relationships to support execution, capacity, quality, specialized capability, print readiness, study support, and process reliability.
- Ensure vendors and external partners understand applicable expectations, timelines, deliverable standards, documentation needs, and escalation pathways.

**Quality, Compliance and Inspection Readiness**

- Ensure Instructional Design and Labeling Operations activities are performed and documented in accordance with applicable procedures, standards, and regulatory expectations.
- Promote strong documentation practices, including traceability of inputs, decisions, reviews, revisions, approvals, study support activities, and submission-related deliverables.
- Support audit readiness, inspection readiness, and response to Health Authority questions or feedback related to Instructional Design and labeling operations deliverables.
- Drive a culture of quality ownership, right-first-time execution, and continuous learning from errors, rework, study outcomes, stakeholder feedback, and process metrics.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications

**Basic Qualifications:**

- Doctorate degree and 2 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience OR
- Masters degree and 6 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience OR
- Bachelors degree and 8 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience OR
- Associates degree and 10 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience OR
- High school diploma / GED and 12 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

And

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Demonstrated people leadership experience, including coaching, performance management, career development, workload management, and building high-performing teams.
- Experience leading FTEs, external workers, contractors, vendors, or matrixed contributors in a regulated or quality-sensitive environment.
- Experience in regulated medical product labeling, artwork, packaging, Human Factors, medical device, pharmaceutical, biotechnology, combination product, quality, or design operations.
- Combination product experience preferred; broader regulated medical space labeling or artwork experience may be suitable.
- Experience improving processes, implementing SOPs, developing templates/checklists, defining role clarity, and scaling functional operations.
- Experience owning or governing controlled procedures, including implementation, adherence, training, inspection readiness, and continuous improvement.
- Knowledge of IFUs, instructional materials, labeling/artwork development, Human Factors study materials, Health Authority submission support, or regulated document workflows.
- Experience with document management systems, review workflows, source text/artwork alignment, traceability, and audit-ready documentation.
- Vendor management experience, including defining expectations, managing deliverables, monitoring performance, and resolving quality or timeline issues.
- Strong cross-functional leadership and influencing skills with the ability to align stakeholders across technical, regulatory, quality, operational, and design perspectives.
- Ability to manage multiple priorities, identify risks, escalate appropriately, and drive decisions in a matrixed environment.
- Strong written, verbal, facilitation, and executive communication skills.
- Demonstrated ability to translate customer, patient, user, and business needs into practical operational improvements.
- Lean, Six Sigma, process excellence, change management, or operational excellence experience preferred.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

California

Senior Associate Manufacturing

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Associate Manufacturing**

**What you will do**

Lets do this! Lets change the world!

The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on:

- Characterization, data, and equipment management
- Process improvement projects/assignments within operations
- Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support
- Support new product introduction activities
- Support production
- Maintain open communication between operations teams

This Senior Associate position will be focused on manual visual inspection operations.

Job Scope and Responsibilities:

- Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
- May schedule operations for multiple functional areas
- Understand process parameters and can identify process anomalies
- Perform data analysis of critical process parameters
- Operate complex critical processing equipment
- Assist, plan and implement continuous improvement solutions related to routine functions
- Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
- Primary resource related to processing operations on the mfg. floor
- Identify and propose solutions to complex problems
- Responsible for resolving problems during operations
- Perform initial review of manufacturing procedures/batch records
- Review, revise, and audit documents
- Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
- Provide process theory expertise and hands-on training to others
- Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
- Applies research, information gathering, and interpretation skills to problems of diverse scope
- Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments
- Recognizes and escalates problems
- Able to establish working relationships with others outside area of expertise
- Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
- Organizational skills and an ability to perform assignments with a high degree of attention to detail
- Written and oral communication skills. Technical writing capability
- GMP knowledge with ability to interpret and apply applicable regulations

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

**Basic Qualifications:**

Masters degree OR

Bachelors degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR

Associates degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR

High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

**Preferred Qualifications:**

- Prior experience with lab equipment, computers, and intermediate mathematical skills
- Significant experience with manual visual inspection in a GMP regulated environment.
- Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
- Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
- Demonstrated technical writing skills
- Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
- Demonstrated ability to work in a team

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Manufacturing SystemsEngineer:Automation- DeltaV (Swing Shift Monday- Friday)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team,youllhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities thatliewithin them,youllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Manufacturing SystemsEngineer:Automation - DeltaV**

**What you will do**

Letsdo this.Letschange the world.As aManufacturing SystemsEngineer,you willwork with agroup ofautomationengineers whoare responsibleforbuildingandmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

**\*The schedule for this position willbe:SwingShift3pm - 11pm: MondaythroughFriday.\***

In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robustprocess automation systemstooperatethe new plant.

Responsibilities:

- Develop andmaintainthe process control system on EmersonDeltaVdistributed control system (DCS).

- Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems.

- Provide clear documentation for delivered solutions andprocesses.

- Support QA partners in performing computerized systems validation in aGxPenvironment.

- Perform Data Integrity Assessments (DIA)in accordance withthe current Amgen and industry standards.

- Supportprocess automationsystemsto ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.

- Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.

- Develop andmaintainengineering and maintenance documentation, and associated procedures for delivered solutions and processes.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

- **Site Operations**

- Own and drivetocompletionChange Controls, CAPAs, and Deviations.

- Supporttechnical root cause analysis, incident investigations, and troubleshooting.

- Support functional area projects focused on improving process equipment,utilities,andfacilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.

- Drive continuous improvement forprocess automation systemsto improve operational workflows, safety, reliability, efficiency, and sustainability.

- Supportday-to-dayoperationsincluding rotational on-callsupport.

- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

- Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

**What we expectfromyou**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications**

- High School Diploma / GED and 8 years of Engineering experience OR

- Associates Degreeand 6 years of Engineering experience OR

- Bachelors Degree and 2 years of Engineering experience OR

- Masters Degree

**Preferred Qualifications**

- Degree in Electrical Engineering,Computer Science, Chemical Engineering,Biotech Engineering,or relatedfield.

- Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors,solution prep,single use mixingvessels,chromatography,TFFL/TFFX,viral filtration, viral inactivation,UF/DF,depth filtration, drug substance fill,CIP/SIP, clean utilities,and integrating various OEM automation software.

- Experienceinprogramming,installation,and lifecycle management of automation and field instrumentation technologies.

- Experiencein programming, design, installation and lifecycle management of manufacturing process controls,andautomation and field instrumentation technologies.

- Experience with EmersonDeltaVDCS systemandability to perform advanced troubleshooting,and systemintegration using OPC, Foundation Fieldbus,andProfibustechnologies.

- Ability to interpret and apply GAMPs and GMPs,and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95.

- Self-directed team playerable to work cross-functionally.

- Strong technical writing and communicationskills.

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.From our competitive benefits to our collaborative culture,wellsupport your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply nowfor a career that defies imagination**

In our quest to serve patientsabove all else, Amgen is the first to imagine and the last to doubt. Join us.

careers.amgen.com

\#AmgenNorthCarolina

Senior Manufacturing Systems Engineer:Automation- DeltaV(Swing Shift Monday - Friday)

ANC1 F&E Engineering

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Senior Manufacturing Systems Engineer:Automation- DeltaV**

**Live**

**What you will do**

Letsdo this.Letschange the world.AsaSeniorManufacturing SystemsEngineer,you will provideautomationtechnical leadership to a group ofautomationengineerswhoare responsible forbuilding andmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

**\*The schedulefor this position willbe:SwingShift3pm - 11pm: MondaythroughFriday.\***

In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robustprocessautomation systems tooperatethe new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecyclemanagementand Operational Excellence.

Responsibilities:

- Develop andmaintainthe process control system onEmersonDeltaVdistributed controlsystem(DCS).

- Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.

- Collaborate with business partners to understandhowautomationcan improve workflow and productivity.Synthesize requirements from clients,customersor end-users to develop the best automation solutions.

- Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in aGxPenvironment.Maintain Data Integrity Assessments with the current Amgen and Industry standards.

- Build the business processes to support theprojectscope in alignment with project timelines. Develop detailedspecificationand engineering policies and procedures that affect multiple organizational units.

- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

- On-going operations:

- Own and drive tocompletionChange Controls, CAPAs, and Deviations.

- Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.

- Leadandsupport technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.

- Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchanges,and supporting engineering and process qualification runs as applicable.

- Manage Day-to-day Operational Support including:24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,Process andUtilityAutomatonsystems,Preventive andCorrectiveMaintenance,SystemAdministration,andAutomation Systemspare parts management.

- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.

- Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications.

**Basic Qualifications:**

- High School Diploma / GED and10years of Engineering experience OR

- Associates Degreeand8years of Engineering experience OR

- Bachelors Degree and4years of Engineering experience OR

- MastersDegree and2years of Engineering experience OR

- DoctorateDegree

**Preferred Qualifications:**

- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or relatedfield.

- Direct knowledge of Automation System design, experience inprocess control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automationsuch asmedia, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.

- Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.

- Experience with EmersonDeltaVDCS system, Process Control Network design including network segregation,virtualinfrastructure design and implementation,and ability to perform advanced troubleshooting activities,systemintegration using OPC, Foundation Fieldbus, Profibus, andDeviceNettechnologies.Experience withDeltaVLive is preferred.

- Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.

- Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.

- Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.

- Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g.cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.

- The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

- Strong leadership, technical writing, and communication/presentation skills.

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that defies imagination**

In our quest to serve patientsabove all else, Amgen is the first to imagine, and the last to doubt. Join us.

**careers.amgen.com**

**#AmgenNorthCarolina**

Associate Director Process Development

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Associate Director, Commercial Drug Products & Life Cycle Management**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be part of Amgens Process Development organization, Drug Product Technologies unit that continuously strives to be a technical leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, life cycle changes, regulatory submissions, annual product reviews, etc. DPTLs are part of an integrated operations team and lead a technical team responsible for delivering drug product process transfers, process optimization, process trouble shooting, timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking an Associate Director to lead commercial drug product programs as DPTL and lead a scientific team that supports advancing the commercial drug product programs in our portfolio.

- Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations.
- Lead a team of scientists focused on late-stage drug product process development and tech transfer and coach staff with emphasis on people-centered leadership.
- Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
- Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
- Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
- Ability to travel domestically and internationally up to 10% of the time.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree and 3 years of experience in engineering or science **OR**

Masters degree and 7 years of experience in engineering or science **OR**

Bachelors degree and 9 years of experience in engineering or science **OR**

Associates degree and 12 years of experience in engineering or science **OR**

High school diploma / GED and 14 years of experience in engineering or science

**And**

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- PhD from an accredited college or university in one of the following areas Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
- 8+ years of pharmaceutical development and management experience
- 8+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
- Demonstrated knowledge of drug product commercialization and integrated combination product development with hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
- Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
- Strong knowledge about developing processes with single-use manufacturing equipment
- Aseptic processing experience and familiarity with cGMPs, ICH guidelines
- Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Strong problem solving and effective cross-functional communication skills
- Proven ability to learn and act on dynamic information at a rapid pace
- Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and strong cross functional relationships

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Senior Manager Manufacturing Systems Engineering - Automation (Multiple Positions)

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team,youllhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities thatliewithin them,youllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

We are hiring **two Senior Manager, Manufacturing Systems Engineering** positions, each with a distinct area of focus:

- **Senior Manager Automation Systems:**  Responsible for leading and supporting **Building Automation Systems (BAS/QBAS), Rockwell PLC platforms, Upstream Process Control Systems (PCS), and Clean Utility PCS**.
- **Senior Manager Manufacturing & Project Delivery:**  Responsible for **New Product Introduction (NPI) delivery, project implementation, manufacturing shift floor support, and Downstream Process Control Systems (PCS)** .

Indicate area of interest and relevant experience as it aligns with one or both of these leadership opportunities.

**Senior Manager Manufacturing Systems Engineering - Automation**

**What You Will Do**

Letsdo this.Letschange the world. In this role The Senior Manageris responsible forproviding technical and administrative leadership to a group of Automation Engineers accountable for administrating andmaintainingautomation systems for Drug Substance manufacturing at AmgenNorth Carolina(ANC). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation teamappliesthe Corporate Automation Business Processes and drivers to deliver the automation services to theorganization.

As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering atAmgenNorth Carolina. This role is expected to provide leadership as follows:

- Lead a team of Automation Engineers and serve as the main point of contact for automation function forANC1manufacturing.Systems including Allen Bradley PLCs, SiemensDesigoCCforbuildingautomation, and EmersonDeltaVfor process control.

- Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing.

- Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.

- Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources.

- Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.

- Providinput into departmentobjectivesandestablishingstrategic direction within the Drug Substance Network for the F&E automation team.

- Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on Maintenance Excellence systems failures and recurrence avoidance.

- Work with diverse groups (Manufacturing, Quality, PD, Automation,Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

- Identifyareas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement.

- Ensure site readiness and compliance for internal audits, external agency audits, and partner audits.

- Ensure the safety of all personnel during plant operations and engineering activities.

- Develop expense budgetforecastand adhere to department budgets and spendforoperational and capital expenses, holding 100% accountability.

- Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

- Ensure Amgen Enterprise cyber resiliency compliance ismaintainedat 100%.

- Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time(RFT) delivery of automation solutions.

- Ensure that reporting functionality is incorporated for all unit operations forproductionBatch records, cleaning, and sterilization systems, including Audit trail and version control.

- Responsible for ensuring that service contracts with all OEMs for systems areestablishedfor service and support needs, including service banked hours for specialized support needs.

- Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.

- Ensure the automation staff are fully aware and confident to work on all automation systems, process equipment, andfacilityto provide 24x7 reliable plant automation support.

- Responsible for ensuring that the automation team activelyparticipatesin daily/weeklyWork Center Team (WCT)meetings Manufacturing area& plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.

- Responsible for ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.

- Provide active leadership such that proactive feedback issolicitedfrom the automation staff and actions are taken tomaintainproper work-life balance.

**What We ExpectOfYou**

We are all different, yet we all use our unique contributions to serve patients. The engineering management professional weseekwillpossessthese qualifications.

**Basic Qualifications:**

- High school diploma / GED and 12 years of Engineering and/or ProjectManagement experience OR

- Associates degree and 10 years of Engineering and/or Project Management experience OR

- Bachelors degree and 8 years of Engineering and/or Project Management experience OR

- Masters degree and 6 years of Engineering and/or Project Management experience OR

- Doctorate degree and 2 years of Engineering and/or Project Management experience

- Additionally: In addition to meeting at least one of the above requirements, you must have a minimum of 2years experiencedirectly managing people and/or leadership experience leading teams, projects, programs, or directing the allocationorresources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field

- Experience with EmersonDeltaVDCS system, SiemensDesigoCC, Allen BradleyPLCand ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies

- Direct knowledge of automation system design

- Experience in programming, installation and lifecycle management of automation and field instrumentation technologies

- Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography,single usemixing vessels, depth filtration, and solution prep

- Experience in integrating various OEM automation software

- Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.

- Fieldbus, and Profibus technologies

- Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95

- Self-directed team player able to work cross-functionally

- Strong leadership, technical writing, and communication skills

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply nowfor a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

\#AmgenNorthCarolina

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

**HOW MIGHT**YOU**DEFY IMAGINATION?**

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experience,and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Front Line Manufacturing Manager - Bulk Drug Substance Services - Days**

**What youwill do**

Letsdo this.Letschange the world.Amgen is seeking aManagerManufacturingServicesto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingoperationsincludingRaw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave, and material handling,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.

The Manager will play a critical role supporting the design,build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.

This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.

**Responsibilities**

- **Frontline Leadership:** Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.

- **Facility Startup & Operational Readiness:** Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.

- **Manufacturing Operations**: Ensure safe, cGMPcompliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.

- **Technology Transfer & Process Implementation:** Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.

- **CrossFunctional Collaboration:** Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.

- **Compliance & Inspection Readiness:** Maintaininspection readiness and adherence to regulatory and Amgen quality standards.

- **Continuous Improvement:** Identifyand drive efficiency, reliability, and scalability improvements as operations mature.

- **Shift Support:** Work nonstandard hours asrequired, transitioning to a 12hour 223 dayshift supporting 24/7 operations.

**Win**

**What we expect from you**

We are all different, yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications.

**Basic Qualifications**

- Doctoratedegree OR

- Masters degreeand3years ofManufacturing or Operationsexperience OR

- Bachelors degree and5years ofManufacturing or Operationsexperience OR

- Associates degree and 10 years of ManufacturingorOperations experience OR

- High school diploma / GED and 12 years of ManufacturingorOperations experience

- **AND** Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

**Preferred Qualifications**

- Bachelors degree in Life Sciences or Engineering

- Experience with facility startup, commissioning, or operational readiness

- Biologics / drug substance manufacturing experience (Services)

- cGMP manufacturing experience (5+ years preferred)

- Experience with technology transfer and process implementation

- Prior Area Lead / Specialist / Manager experience

- Strong leadership, performance management, and conflictresolution skills

- Solid understanding of regulatory requirements

- Proficiencywith MES/EBR,DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply nowfor a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

**#AmgenNorthCarolina**

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens next generation drug substance manufacturing facility in North Carolina. We are starting up our first facility and breaking ground on our second facility. Both facilities feature the best in-class drug substance technologies and integrate sustainability innovations to reduce carbon and waste, as part of Amgens plan to be a carbon-neutral company by 2027.

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

**Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days**

**What you will do**

Letsdo this.Letschange the world.Amgen is seeking a Manager ManufacturingUpstreamto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.

The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.

This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.

**Responsibilities**

- **Frontline Leadership:** Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.

- **Facility Startup & Operational Readiness:** Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.

- **Manufacturing Operations**: Ensure safe, cGMPcompliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.

- **Technology Transfer & Process Implementation:** Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.

- **CrossFunctional Collaboration:** Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.

- **Compliance & Inspection Readiness:** Maintaininspection readiness and adherence to regulatory and Amgen quality standards.

- **Continuous Improvement:** Identifyand drive efficiency, reliability, and scalability improvements as operations mature.

- **Shift Support:** Work nonstandard hours asrequired, transitioning to a 12hour 223 dayshift supporting 24/7 operations.

**Win**

**What we expect from you**

We are all different, yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications.

**Basic Qualifications**

- Doctoratedegree OR

- Masters degreeand3years ofManufacturing or Operationsexperience OR

- Bachelors degree and5years ofManufacturing or Operationsexperience OR

- Associates degree and 10 years of ManufacturingorOperations experience OR

- High school diploma / GED and 12 years of ManufacturingorOperations experience

- **AND** Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

**Preferred Qualifications**

- Bachelors degree in Life Sciences or Engineering

- Experience with facility startup, commissioning, or operational readiness

- Biologics / drug substance manufacturing experience (Upstream)

- cGMP manufacturing experience (5+ years preferred)

- Experience with technology transfer and process implementation

- Prior Area Lead / Specialist / Manager experience

- Strong leadership, performance management, and conflictresolution skills

- Solid understanding of regulatory requirements

- Proficiencywith MES/EBR,DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

- Stock-based long-term incentives

- Award-winning time-off plans and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

**Apply nowfor a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

**#AmgenNorthCarolina**

PI Historian Application Owner - Manufacturing Systems Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**PI Historian Application Owner - Manufacturing Systems Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen Technology Team technical roadmaps.

Seeking candidates who possess expertise in business, automation systems, information/data management and technical experience in database and data historian technologies and integration tools.

**Responsibilities:**

- Own and support Aveva PI Data Historian activities, ensuring system reliability, data integrity, and issues resolution.
- Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).
- Own and craft the design and technology of the Technology ecosystem.
- Support and/or be responsible for the execution of a varied portfolio of Technology and automation platforms projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.
- Crafting Amgen's future Keep track of industry and technology trends, connect, and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.
- Support cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solutions. Lead multiple initiatives and priorities.
- Effectively manage relationships with Technology service owners, business partners, enterprise Technology service partners, and vendors.
- Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.
- Manage Technology platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
- Domestic and international travel up to 25%.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

**Basic Qualifications:**

Masters degree

OR

Bachelors degree and 2 years of Information Systems, Engineering and/or Information technology experience

OR

Associates degree and 6 years of Information Systems, Engineering and/or Information technology experience

OR

High school diploma / GED and 8 years of Information Systems, Engineering and/or Information technology experience

**Preferred Qualifications:**

- 4+ years experience in a manufacturing environment with 2+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries.
- 2+ years combined experience with the following product platforms: Data Historian (AVEVA PI), MES (Korber), Delta V Automation platform, and/or Rockwell Platform Automation Systems.
- 2+ years combined experience with IIoT (Industrial Internet of Things).
- General experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping) is helpful.
- Experience working with Agile development methodologies.
- Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.
- Knowledge of industry standards for SDLC methodologies and 21 CFR Part 11.
- General experience with computer validation and change control methodology.
- Experience with computerized systems including troubleshooting, reliability, and performance improvements.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Global Safety Medical Director, Rare Disease

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Global Safety Officer, Medical Director, Rare Disease**

**What you will do**

Lets do this. Lets change the world.In this vital role, you will serve as the strategic safety leader for assigned Rare Disease assets within Amgen's global development organization. You will be accountable for the overall benefit-risk profile, safety strategy, signal management, and safety governance of clinical programs, with a primary focus on early clinical development (Phase 1b and Phase 2 studies).

This role is ideal for a physician who has served as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety leader for development-stage assets and has directly influenced key clinical development decisions through safety leadership.

The successful candidate will bring expertise in Rare Disease drug development and ideally experience within inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications.

You will establish the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and safety-related decisions for assigned products.

You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee (ESC). You will partner closely with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to influence development strategy and support innovative therapies for patients with rare diseases and high unmet medical need.

**Responsibilities:**

- Serve as the accountable physician safety leader for assigned Rare Disease development programs.
- Lead global safety strategy for clinical development programs with a primary focus on Phase 1b and Phase 2 studies.
- Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions.
- Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.
- Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.
- Lead Safety Analysis Team (SAT), Global Safety Team (GST), and participate in Executive Safety Committee (ESC) discussions.
- Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.
- Validate safety signals and lead signal detection, assessment, and risk evaluation activities.
- Develop and maintain Core Safety Information including Core Data Sheets and informed consent safety language.
- Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports.
- Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.
- Prepare and review safety sections of regulatory submissions including INDs, CTAs, BLAs, NDAs, and other global submissions.
- Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.
- Support regulatory inspections and inspection readiness activities.
- Domestic and international travel up to 10%.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Global Safety Officer we seek is a leader with these qualifications.

**Basic Qualifications:**

MD or DO degree from an accredited medical school

AND

Completion of an accredited medical or surgical residency

OR

Relevant clinical experience in an academic, hospital-based, or private practice setting.

**Preferred Qualifications:**

- 8+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development.
- Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role.
- Significant experience supporting Phase 1b and Phase 2 clinical development programs.
- Experience in Early Clinical Development, including First-in-Human, dose escalation, cohort expansion, proof-of-concept, and translational medicine programs.
- Direct experience influencing clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments.
- Expertise in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance.
- Experience supporting regulatory submissions and interactions with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responses to regulatory questions.
- Experience presenting safety assessments and recommendations to governance committees, development teams, and regulatory authorities.
- Experience supporting Rare Disease clinical development programs strongly preferred.
- Expertise in inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications strongly preferred.
- Experience supporting biologics, monoclonal antibodies, gene therapies, or other innovative modalities in clinical development preferred.
- Demonstrated leadership in cross-functional matrix organizations with the ability to influence development strategy and drive decision-making.
- Experience with both clinical development and post-marketing safety activities preferred.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

District of Columbia

GenScript

Warehouse Specialist

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Scope:**

We are seeking a detail-oriented and reliable **Warehouse Specialist** to support daily operations for raw materials and finished goods. The ideal candidate has hands-on warehouse experience, strong problem-solving skills, and the ability to work in a fast-paced environment while maintaining accuracy and compliance.

Please note that this role is based onsite in **Redmond, WA** and will pay approximately $26 - $30 per hour, dependent upon experience level.

**Job Responsibilities:**

- Audits each shipment prior to packing to ensure that goods are in sellable condition and match order
- Picks, Packs and labels product based on established standards.
- Follow established Standard Operating Procedures (SOPs) to ensure consistent and compliant operations
- Process inbound and outbound shipments, including sorting, picking, packing, shipping, and system transactions in SAP/WMS
- Inspect incoming materials for damage or discrepancies; coordinate with Purchasing to resolve issues
- Prepare, review, and maintain accurate shipping and receiving documentation; ensure proper record retention for compliance
- Perform inventory cycle counts, investigate discrepancies, and support corrective actions
- Troubleshoot and resolve operational issues such as shipping delays or inventory variances; provide clear feedback and solutions
- Maintain a safe, clean, and organized warehouse environment in compliance with EHS and 5S standards

**Qualifications:**

- High school diploma or equivalent required; Associate’s degree or higher in Supply Chain or a related field preferred
- Previous experience in warehouse operations required
- Experience with warehouse systems such as SAP, WMS, or similar platforms preferred
- Proficient in Microsoft Office (Excel, Outlook, Word)
- Ability to lift and move up to 45 lbs as needed
- Bilingual (Chinese/English) is a plus
- Strong attention to detail and organizational skills
- Effective communication skills with the ability to work across different levels of the organization
- Strong problem-solving ability and a proactive approach to work
- Ability to work independently as well as part of a team in a fast-paced environment.

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Washington

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Scope:**

We are seeking a detail-oriented and reliable **Warehouse Specialist** to support daily operations for raw materials and finished goods. The ideal candidate has hands-on warehouse experience, strong problem-solving skills, and the ability to work in a fast-paced environment while maintaining accuracy and compliance.

Please note that this role is based onsite in **Seattle, WA** and will pay approximately $26 - $30 per hour, dependent upon experience level.

**Job Responsibilities:**

- Audits each shipment prior to packing to ensure that goods are in sellable condition and match order
- Picks, Packs and labels product based on established standards.
- Follow established Standard Operating Procedures (SOPs) to ensure consistent and compliant operations
- Process inbound and outbound shipments, including sorting, picking, packing, shipping, and system transactions in SAP/WMS
- Inspect incoming materials for damage or discrepancies; coordinate with Purchasing to resolve issues
- Prepare, review, and maintain accurate shipping and receiving documentation; ensure proper record retention for compliance
- Perform inventory cycle counts, investigate discrepancies, and support corrective actions
- Troubleshoot and resolve operational issues such as shipping delays or inventory variances; provide clear feedback and solutions
- Maintain a safe, clean, and organized warehouse environment in compliance with EHS and 5S standards

**Qualifications:**

- High school diploma or equivalent required; Associate’s degree or higher in Supply Chain or a related field preferred
- Previous experience in warehouse operations required
- Experience with warehouse systems such as SAP, WMS, or similar platforms preferred
- Proficient in Microsoft Office (Excel, Outlook, Word)
- Ability to lift and move up to 45 lbs as needed
- Bilingual (Chinese/English) is a plus
- Strong attention to detail and organizational skills
- Effective communication skills with the ability to work across different levels of the organization
- Strong problem-solving ability and a proactive approach to work
- Ability to work independently as well as part of a team in a fast-paced environment.

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Manufacturing Supervisor (Lean Manufacturing)

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Position Overview:**

We are seeking a results-driven and people-focused **Production Supervisor (Lean)**  to oversee our **manufacturing floor**. In this role, you will manage a dedicated team of 10–12 technicians and production personnel, driving daily execution while fostering a high-retention, supportive team culture. The primary focus of this position is **direct, manufacturing team management** and field management rather than project-heavy initiatives. The ideal candidate blends experience in field management, manufacturing experience, exceptional people management skills with practical Lean experience—keeping the floor running smoothly, maintaining high team morale, and leveraging Lean methodologies to drive continuous process improvements across our laboratory operations. As a core driver of lean management, the Lean Supervisor is responsible for enhancing production operational efficiency, reducing waste, and optimizing processes through systematic metrics control, project implementation, lean training, and activity planning. This role requires aligning with company strategy to implement the lean management system, coordinating cross-departmental resources, and achieving continuous improvement in key areas such as cost, quality, and delivery.

The estimated salary range is $80,000 - $100,000, depending on experience.

**Qualifications & Requirements**

- **Experience:**
  - **Direct On-Site Team Management:**  Minimum of **3+ years** of hands-on floor team management experience in a manufacturing or production setting.
- **Leadership Track Record:**  Demonstrated success managing teams of 10+ lab technicians with a strong record of staff retention, conflict resolution, and driving a positive team culture.
- **Lean Expertise:**  Solid understanding and practical application of Lean manufacturing principles applied directly to daily shop-floor production operations.
- **Communication:**  Strong communication skills with the ability to manage up to factory leaders and support hands-on floor personnel effectively.

**On-Site Team Leadership & Retention (Primary Focus)**

- Direct, mentor, and manage a team of 10–12 technicians and floor specialists on the production floor.
- Cultivate an engaging, supportive workplace culture that minimizes turnover and drives high employee retention.
- Conduct regular performance reviews, feedback sessions, and skill matrix development for floor staff.
- Balance workload distribution, shift handovers, and resource management to keep the team engaged and working effectively.

**Floor Operations & Factory Alignment**

- Supervise daily molecular biology production lines, ensuring output targets, safety guidelines, and quality compliance (ISO/GMP) are consistently met.
- Act as the key operational bridge between floor technicians, cross-functional teams, and factory management.
- Troubleshoot daily operational bottlenecks, equipment availability, and material supply to prevent downtime on the floor.

**Lean & Continuous Improvement (Secondary Focus)**

- Utilize Lean tools and methodologies (5S, Gemba walks, Kaizen, Root Cause Analysis) to streamline workflow efficiency and reduce waste on the floor.
- Facilitate continuous improvement initiatives directly on the floor alongside technicians and factory managers without disrupting active production output.

**Requirements:**

**Professional Background:**

- Bachelor's degree or higher, preferably in Industrial Engineering (IE), Mechanical Engineering, Molecular Biology, Biotechnology, Life Sciences, Manufacturing, or related fields.
- Certification in lean production, Six Sigma (Green Belt or above preferred).
- Leading or assisting in cross-departmental lean improvement projects (e.g., 5S, TPM, VSM, SMED, standardized work).

**Core Competencies:**

- Data Analysis: Proficient in using Excel and other data analysis tools to identify improvement opportunities.
- Project Management: Experienced in cross-departmental collaboration and adept at driving project implementation.
- Communication and Training: Clear logic and structured expression skills.
- Tool Application: Proficient in using lean tools like A3 reports, standardized work, ECRS.

\#LI-EB1

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

New Jersey

mRNA Manufacturing Intern (Full Time)

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**About GenScript**

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. For more details, welcome to visit our website [www.genscript.com](<https://www.genscript.com>).

**Position Overview**

- Process DNA via PCR, digestion, and purification to prepare template for in-vitro transcription.
- Perform various enzymatic reactions to produce and process mRNA.
- Purify mRNA using HPLC, spin columns, and other technologies.
- Run quality checks on in-process and final products. This includes gel electrophoresis, capillary electrophoresis, RT-PCR, cell expression, HPLC, dot blot, and more.
- Follow production S.O.P.s to ensure compliance to validated processes.
- Document all processes and materials used on all products.
- Keep track of inventory using an inventory management system.
- Order materials internally and externally for production use.
- Any other tasks needed as deemed by production manager.

**Qualifications**

- Bachelor’s degree Biology or Chemistry related field.
- Experience working with mRNA is a plus.
- Experience with PCR, HPLC, or enzymatic reactions is desired.
- Ability to work as part of a small cross-disciplinary team to accomplish both short term and long term goals.
- Experience successfully working in a fast-pace, high-demand environment is highly desirable.
- Ability to communicate with peers and managers in a polite and concise manner is highly desirable.

Please note that this is a **full-time** role based onsite in Redmond, WA with lunch provided daily. The hourly pay-rate is $22-$24 per hour.

Please note that we are not looking for candidates that are unable to commit to a full-time schedule of 40 hours per week.

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

mRNA Production Technician

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

GenScript’s European division, headquartered in Rijswijk, Netherlands, with a branch office in Oxford, UK, was established in 2019 to serve as a regional hub for commercial operations, technical support, and logistics across Europe and the UK. In 2025, we reached a new milestone with the launch of our new production facility in Delft, Netherlands - strengthening our long‑term commitment to operational excellence and enhanced service delivery for our EU customers. This expansion reflects GenScript’s dedication to innovation and our growing presence in the European biotech landscape. In this role, you will join the team responsible for producing mRNA at our Delft facility. Working in a collaborative and hands-on laboratory environment, you will contribute to the manufacturing, purification, quality control, and documentation of mRNA products, helping ensure reliable delivery to researchers and biotech innovators across Europe.

**Job title:** mRNA Production Technician

**Location:** Biotech Campus Delft, South Holland, Netherlands

**Scheme:** 100% onsite

**Time:** Full‑time (40 hours / week) Mon-Fri 9:00-17:30.

**What You'll Be Doing**

- Process DNA via PCR, digestion, and purification to prepare template for in-vitro transcription.
- Perform various enzymatic reactions to produce and process mRNA.
- Purify mRNA using HPLC, spin columns, and other technologies.
- Run quality checks on in-process and final products. This includes gel electrophoresis, capillary electrophoresis, production raw materials and consumables etc.
- Follow production S.O.P.s to ensure compliance to validated processes.
- Keep good documentation for production processes and materials used in process.
- Keep track of inventory using an inventory management system.
- Order materials internally and externally for production use.
- Assists with the multistep synthesis and process development of key reagents.
- Conduct routine lab maintenance procedures.
- Any other tasks needed as deemed by production manager.

**What We Expect From You**

- Completed MBO Level 4, Associate Degree (Ad), HBO Bachelor's degree, or an equivalent international qualification in Biotechnology, Life Sciences, Molecular Biology, Biochemistry, Chemistry, or a related scientific discipline.
- Experience working with mRNA or oligonucleotide chemistry.
- Experience with PCR, HPLC, or enzymatic reactions.
- Experience with techniques commonly used in the isolation and characterization of organic intermediates (column chromatography, HPLC, MS, etc.).
- Ability to work as part of a small cross-disciplinary team to accomplish both short term and long term goals.
- Experience successfully working in a fast-pace, high-demand environment is highly desirable.
- Ability to communicate with peers and managers in a polite and concise manner is highly desirable.
- Fluent in English.
- Please note that GenScript does not provide sponsorship for work visas for this position. **Applicants must have the legal right to work in the Netherlands** for at least three years and reside in or within a reasonable commuting distance from Delft.

**What We Offer**

- A performance‑based target bonus, linked to individual achievements.
- 25 days of annual leave, plus all Dutch bank holidays.
- Complimentary warm lunch on onsite working days to keep you fueled.
- Access to professional well-being support and consultant.
- Commuting allowance, 8% holiday pay, and a pension scheme with a 2% personal contribution.
- Quarterly team‑building activities and international working environment.
- Free parking available on the premises.

**Interview Process**

1. Online introductory call with our recruiter.
2. Online interview with a hiring manager.
3. Final online panel interview with the hiring managers and main stakeholders.

*The selection process may include a reference check.*

\#GS #LI-AH1

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Other Non-US

Senior EHS Specialist (Environment, Health & Safety)

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Title:** Sr. EHS Specialist

**Location:** Piscataway, NJ (Fully Onsite)

**Reports to:** Director of US Site Operations

**Compensation:** The estimated salary range is $85,000 - $100,000, based on experience.

**Job Overview:**

This role supports EHS programs for our New Jersey research labs, including BSL-2 areas. The Senior EHS Specialist will help implement and maintain lab safety, chemical hygiene, biosafety, waste management, emergency response, and contractor safety processes. The role works independently on routine and moderately complex EHS matters, while partnering with senior EHS, Facilities, and lab leadership on complex facility design, construction, or regulatory issues.

This is a hands-on role that requires regular presence in labs and project areas to identify risks, support corrective actions, and help ensure EHS procedures are followed. The role is expected to follow through on assigned actions and help improve existing programs, with escalation of novel or high-impact risks as appropriate.

**Job Responsibilities:**

- Implement and maintain established EHS programs for research labs, including chemical hygiene, hazard communication, PPE, lockout/tagout, waste management, procedures, and training materials.
- Support BSL-2 biosafety activities, including biological waste handling, spill response procedures, lab audits, and corrective action follow-up.
- Conduct regular lab and facility inspections and verify safety equipment such as fume hoods, eyewash stations, safety showers, and fire extinguishers.
- Maintain chemical inventory records and SDS library, and support proper chemical storage and labeling practices.
- Assist with exposure monitoring, such as air sampling or noise checks, and recommend controls for review by senior EHS or site leadership.
- Review new equipment, lab moves, and process changes for EHS risks using established procedures; escalate complex findings as needed.
- Support EHS review of facility designs, including lab layout, ventilation, chemical and biological storage, and egress, and help track EHS-related items through construction and start-up.
- Participate in contractor safety activities, including reviewing safety documentation, supporting work permit processes, conducting site walks, and following up on assigned findings.
- Maintain emergency response plans, support drills, and document improvement actions.
- Deliver EHS training to new hires, lab staff, and contractors, and maintain training records.
- Investigate incidents and near misses using established processes, identify contributing factors, and support corrective action completion.
- Maintain OSHA logs, NJ Right to Know filings, waste manifests, permits, and other EHS records; support regulator and insurer visits.
- Track EHS metrics and report on assigned open issues

**Qualifications:**

- Bachelor’s degree in EHS, environmental science, engineering, or a related field.
- 5+ years of EHS experience.
- Experience in research labs or biotech/pharma, ideally including BSL-2 environments.
- Working knowledge of chemical hygiene, hazard communication, PPE, waste management, incident investigation, inspections, and EHS recordkeeping.
- Exposure to facility design review or construction safety is preferred.CSP, ASP, CHMM, or similar certification is a plus

\#LI-EB1

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Afton Scientific LLC

MS&T Engineer - Drug Product

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

**NOTE: Afton Scientific does not sponsor work visas. No recruiters please.**

Afton Scientific is seeking a technically skilled, collaborative, and solutions-oriented MS&T Engineer - Drug Product to join our Manufacturing Science & Technology team. This position supports sterile fill-finish manufacturing by resolving technical issues, improving processes, and supporting technology transfer, validation, and investigations.

This is an excellent opportunity for an employee who enjoys applying scientific and engineering principles, solving complex manufacturing problems, and partnering across departments to keep operations reliable, controlled, and compliant with cGMP requirements.

**Compensation**

**$95,000 to $145,000 annually**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

• Provide daily technical support for sterile manufacturing and fill-finish operations, including compounding, filtration, filling, and inspection.

• Monitor and analyze process data to identify variability, risks, trends, and improvement opportunities.

• Troubleshoot manufacturing, process, and equipment issues in partnership with Manufacturing, Quality, Engineering, Maintenance, and other teams.

• Lead or support deviation investigations, root-cause analyses, corrective and preventive actions, and effectiveness checks.

• Support product and process technology transfers, scale-up activities, and related plans, studies, protocols, and reports.

• Support process validation, equipment qualification, aseptic process simulations, cleaning validation, and continued process verification.

• Prepare and maintain SOPs, batch records, technical reports, risk assessments, protocols, and other controlled documents.

• Evaluate proposed process, equipment, material, and documentation changes through the established change-control process.

• Design and analyze engineering studies using statistical and quality risk-management tools to improve quality, yield, reliability, and efficiency.

• Provide technical input for equipment decisions, client and regulatory communications, and internal, client, or regulatory audits.

• Train manufacturing personnel, coordinate technical deliverables, and comply with applicable safety, data-integrity, quality-system, and cGMP requirements.

**Minimum Qualifications**

• Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, pharmaceutical sciences, life sciences, or a related technical discipline.

• Three or more years of experience in engineering, technical operations, process development, validation, or manufacturing within the pharmaceutical, biotechnology, or a similarly regulated industry.

• Working knowledge of cGMP requirements and pharmaceutical quality systems.

• Knowledge of process validation, equipment qualification, change control, deviations, investigations, and CAPA systems.

• Ability to investigate complex technical problems and develop practical, scientifically sound solutions.

• Strong analytical, organizational, project-management, and prioritization skills.

• Strong written and verbal communication skills and the ability to work effectively across functions.

• Ability to work on-site and enter controlled manufacturing areas while meeting applicable gowning and personal protective equipment requirements.

**Preferred Knowledge and Experience**

• Experience supporting sterile manufacturing, aseptic processing, or pharmaceutical fill-finish operations.

• Experience working in a contract development and manufacturing organization environment.

• Understanding of contamination-control principles and good documentation practices.

• Experience with root-cause analysis and risk-management tools such as 5 Whys, fishbone analysis, fault-tree analysis, and FMEA.

• Experience preparing technical protocols, reports, procedures, risk assessments, and presentations.

• Experience using electronic quality, manufacturing, or document-management systems.

**Key Competencies**

• Technical Problem Solving

• Process Analysis and Improvement

• Quality and Regulatory Compliance

• Project Management

• Communication and Collaboration

• Attention to Detail

• Sound Judgment and Decision Making

• Initiative and Accountability

**What You'll Gain**

• Hands-on experience supporting sterile fill-finish manufacturing and aseptic processing.

• Increased exposure to technology transfer, validation, investigations, and process improvement.

• Opportunities to collaborate with Manufacturing, Quality, Engineering, Maintenance, and other functional teams.

• Experience contributing directly to product quality, process reliability, yield, and operational efficiency.

• An opportunity to expand technical leadership skills and pursue continued career growth within Afton Scientific.