Manufacturing & Production

Siegfried

R & D Process Manager

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Leads the process R&D function responsible for developing and implementing new processes and improving existing processes for commercial, developmental, and reference standards manufacturing. Assists the business development team by evaluating the technical feasibility of manufacturing new products or supporting technical transfers of products to Athens or external manufactures.

**Your Profile:**

ESSENTIAL DUTIES AND RESPONSIBILITIES

- Responsible for the safety, health and wellbeing of all employees and contractors working in the R&D Laboratory areas in Athens.

- Provides guidance and work direction to department employees.

- Responsible for the development and leadership of employees in Process R&D Group. Is responsible for managing the performance of employees to include involvement in processes such as objective setting, performance reviews, staffing, corrective action, succession planning, training and development, and other key human resource management activities.

- Responsible for the overall performance of the Process R&D Group.

- Responsible for ensuring that key projects for development and process technical transfer are identified, initiated, and executed in a timely fashion.

- Responsible for the technical evaluations of customer requests for proposals with attention to scope, timing, and safety of performing the work in Athens laboratories and plant.

- Plans, performs and reports laboratory work in support of developing new processes, or generating information to support process validation and regulatory filings.

- Develops and proposes new methodologies and evaluates new technologies in order to reduce cost and improve overall process efficiencies.

- Provides technical support and expertise to both internal and external customers such as Production, Process

- Engineering, Regulatory, Quality, EHS and third-party customers and partners.

- Guides, reviews and approves research development reports, as well as documentation associated with process validation and production records.

- Writes technical protocols, reports, procedures, specifications and regulatory documents using scientific and compliant style.

- Responsible for identifying cost savings/avoidance opportunities where appropriate.

ADDITIONAL POSITION REQUIREMENTS

- Successfully completes regulatory and job training requirements.

- Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.

- Assumes responsibility for the environmental effects of work performed for the identification and recording of environmental problems as they arise.

- Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.

- Must be available to work overtime on a scheduled or emergency basis.

- Remains current in skills and industry trends.

- Is available to travel nationally and internationally to undertake the role.

- Is available for other duties as required.

SUPERVISORY RESPONSIBILITIES

- Supervises the Process R&D Group employees at the Athens, GA.

- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

- Responsible for regulatory compliance (DEA, OSHA, cGMP) in the R&D laboratories.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

- Minimum requirements include: Doctoral degree (Ph.D.) with 8+ years of related experience in an R&D laboratory and/or kilo lab/pilot plant with proven track record of process development of APIs.

- Prior experience supervising or managing others preferred. Commercial production experience and knowledge of GLP/cGMP regulations and ICH guidelines is highly preferred.

LANGUAGE SKILLS

- Read, analyze, and interpret the moderately complex technical and regulatory documents.

- Regularly responds effectively to inquiries or complaints from client groups, customers and regulatory agencies.

- Ability to write moderately complex technical reports, business correspondence and technical procedural instructions/manuals.

- Creates presentations using original or innovative techniques, as well as established template formatting.

- Ability to effectively present information and respond to questions from groups of managers, employees, top management, public groups, and/or boards of directors. Makes effective and persuasive presentations on moderately controversial or complex topics.

MATHEMATICAL SKILLS

- Apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.

- Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

- Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

- Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in highly complex phases.

REASONING ABILITY

- Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

- Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases.

- Deal with a variety of abstract and concrete variables.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

- Expert knowledge of organic chemistry and cGMP regulations.

- Demonstrated successful experience with chemical process development, process scale-up and transfer of processes to commercial production.

- Knowledge of modern analytical techniques: HPLC, GC, NMR, XRPD, Particle Size Analysis and interpretation of data from these techniques

- Use computer software and customized programs to meet business needs, including word processing and mathematical applications.

- Must be able to work with people, influencing their output and work behavior.

- Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.

PHYSICAL DEMANDS

- While performing the duties of this job, the employee is frequently required to stand; walk; sit; reach with hands and arms, use hands to finger, handle, or feel.

- Must have fine motor skills to perform precise laboratory manipulations.

- The employee is occasionally required to: climb or balance; stoop, kneel, crouch, or crawl.

- The employee must regularly lift and/or move up to 10 pounds; occasionally lift and/or move up 40 pounds.

- Specific vision abilities required by this job include close vision, peripheral vision, depth perception, color vision, and ability to adjust focus.

- Must be able to qualify for respiratory protective equipment use and must be able to smell surrounding environments.

**Your Benefits:**

- Medical, Dental, Vision

- Flexible Spending & HSA Options

- Life Insurance, Short & Long Term Disability

- Pet Insurance

- Generous PTO, Sick & Holiday Time Off

- 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Georgia

Project Manager II, Pharmaceutical Manufacturing

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The Project Manager II will develop, plan, direct and manage projects associated with drug product manufacturing, aseptic processing and filling for Siegfried Irvine. They will oversee all aspects of projects by working directly with customers and internal support teams, from design of product/costing through coordination of execution of projects through to commercialization. They will have a strong understanding of the process development and product lifecycle and possess a broad range of skills in process analysis, project planning, coordination, and project execution. This position works cross-functionally within Siegfried Irvine site as well as Business Development to ensure business goals are successfully met.

This is an onsite position in Irvine, California.

**Your Profile:**

**_Responsibilities_**

- Assemble project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings. Closely follow-up with projects to ensure project deliverables are met.

- Conduct routine project meetings with external customers and generate meeting minutes

- and action items.

- Assist in developing scope of work for drug product manufacturing projects and technical transfer.

- Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.

- Direct and coordinate the activities of cross-functional project team members such as Engineering, Purchasing, Quality Assurance, Manufacturing and Maintenance, demonstrating a strong ability to function well in a team environment.

- Develop project scope definition, bid package, cost control, commissioning and start up methods and procedures.

- Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring, and closing.

- Establish the communication plans for client facing and internal cross-functional teams.

- Responsible for customer relations and resource utilization.

**_Required Knowledge, Skills and Abilities_**

- Project Management experience in Pharmaceutical, Biotechnology or Medical Device industry with knowledge and experience with pharmaceutical manufacturing processes and equipment.

- Demonstrate Project Management knowledge tools, techniques and culture. Strong

- computer skills. A solid knowledge of Microsoft Oﬃce programs with focus on Microsoft Project and Microsoft SharePoint.

- Aseptic manufacturing experience required. Sterile ophthalmic solution and suspension as well as sterile semi solids experience desired.

- Product development and sustaining engineering knowledge is a plus.

- Ability to effectively communicate with every level in the organization as well as customers and suppliers.

- Excellent written and verbal communication skills.

- Solid organizational skills including attention to detail and multi-tasking skills.

- Capable of motivating others in a dynamic and fast-paced environment. Ability to shift and change priorities as needed.

- Strong leadership skills. Must be capable of using good reason and judgment to make, defend and uphold decisions and recommendations.

- Strong knowledge of GMP’s, CFR’s, ICH and ISO Regulations.

- Familiarity with OSHA, EPA and other federal and local regulatory requirements.

- Must be a self-starter with the aptitude to work independently and use good judgment while performing multiple tasks

**_Required Education and Experience_**

- Bachelor of Science Degree in Science, Engineering or related field.

- PMP certification preferred

- 5+ years’ experience in GMP manufacturing / product development environment

Target Salary Range: $125,000 - 135,000

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision
- Flexible Spending & HSA Options
- Life Insurance, Short & Long Term Disability
- Pet Insurance
- 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

California

Site Engineering & Maintenance Head

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

We are seeking a Director of Engineering & Maintenance to lead critical site functions, drive strategic initiatives, and elevate operational excellence across our pharmaceutical manufacturing operations.

This is a leadership role where technical expertise meets strategic vision. As a key member of the Site Leadership Team (SLT), you will play a pivotal role in shaping the future of our site through engineering innovation, capital project execution, and people development.

Deeper fill & finish, sterile medicinal products and facility/maintenance-focused engineering leadership experience is a must!

**Your Profile:**

**Job Description (Your Profile)**

As Director of Engineering & Maintenance, you will:

- Define and execute the mid and long term engineering strategy aligned with site and corporate goals
- Lead major CAPEX projects from concept through execution—ensuring delivery on time, within budget, and to specification
- Establish and drive robust governance processes to track and improve operational performance
- Oversee Engineering, Maintenance, Facilities, Automation, and Calibration teams
- Ensure equipment reliability, asset lifecycle optimization, and KPI performance
- Partner cross-functionally with Manufacturing, M&ST, Quality Assurance, and Project Management
- Support facility expansions, equipment acquisitions, and site modifications, including qualification activities
- Drive continuous improvement in aseptic operations, clean utilities, and GMP compliance
- Lead technical evaluations, equipment selection, and implementation of advanced manufacturing technologies
- Actively contribute to Deviation, CAPA, and Change Control (DCR) processes
- Manage departmental budgets, including CAPEX and maintenance budgets exceeding $3M
- Develop and mentor a high-performing engineering organization

**What You Bring**

- Strong leadership presence with the ability to inspire, develop, and lead technical teams
- Deep expertise across:
  - Pharmaceutical engineering & fill/finish manufacturing of sterile medicinal products
  - Maintenance & reliability systems
  - Automation & process equipment
  - GMP compliance and aseptic operations
- Proven ability to manage complex capital projects and cross-functional initiatives
- Excellent communication skills with the ability to influence at all levels
- Strong analytical mindset with sound decision-making capabilities
- Proficiency with tools such as AutoCAD, SolidWorks, Microsoft Project, Excel, and related systems

**Required Experience & Education**

- Bachelor’s Degree in Engineering (or equivalent)
- 15+ years of engineering experience in the pharmaceutical industry
- 7+ years leading engineering, maintenance, and facilities teams
- 5+ years of GMP experience, including aseptic processes and clean utilities
- Demonstrated ownership of CAPEX and maintenance budgets \> $3M

Target Base Salary: $240,000 – $270,000

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.*

**Your Benefits:**

We offer a comprehensive and competitive benefits package designed to support your health, wealth, and work-life balance:

- Medical, dental, and vision coverage (including dependents)
- Life insurance, short and long term disability
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- 401(k) with company match
- Generous Paid Time Off (PTO)

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Project Engineer III, Pharmaceutical Manufacturing

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Bring your pharmaceutical manufacturing expertise to a growing CDMO environment where you'll help drive expansion, innovation, and operational excellence.

As a Project Engineer III, you'll lead capital projects supporting manufacturing operations, equipment implementation, facility upgrades, and new product introductions within a GMP-regulated environment. Working closely with Manufacturing, Quality, Validation, and Facilities teams, you'll manage projects from concept through commissioning, qualification, validation, and startup, helping deliver the systems and processes that support critical client programs and life-changing therapies.

This role is ideal for engineers with experience in pharmaceutical, biotechnology, or CDMO manufacturing who enjoy solving complex technical challenges, collaborating across functions, and making a visible impact on manufacturing performance, compliance, capacity growth, and ultimately the patients who rely on the products we manufacture.

**Your Profile:**

**Key Responsibilities**

- Lead CAPEX projects including facility expansions, utility upgrades, equipment installations, and manufacturing process improvements.
- Manage projects from concept through commissioning, qualification, validation, and operational handoff.
- Develop project plans, budgets, schedules, and risk mitigation strategies.
- Coordinate contractors, vendors, OEMs, and cross-functional stakeholders.
- Lead FAT, SAT, and CQV activities, including URS, DQ, IQ, OQ, and PQ documentation.
- Support new product introductions, process optimization, and equipment lifecycle management.
- Drive root cause investigations, CAPAs, and continuous improvement initiatives.
- Ensure compliance with GMP, FDA, and internal quality system requirements.

**Required Qualifications**

- Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related discipline).
- 4+ years of engineering experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
- 2+ years of direct experience in Commissioning, Qualification, and Validation (CQV).
- Proven experience managing CAPEX projects and equipment implementation.
- Strong understanding of GMP manufacturing, validation, and quality systems.
- Experience working in cleanroom environments.

**Preferred Qualifications**

- Experience within a CDMO environment.
- Experience supporting new product introductions and manufacturing scale-up activities.
- Experience working directly with vendors, contractors, and regulatory auditors.

**Target Salary Range: $125,000 - $135,000**

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision
- Flexible Spending & HSA Options
- Life Insurance, Short & Long Term Disability
- Pet Insurance
- 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Sr. Production Planning Specialist

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The Material Planner will evalaute materials demand to support the manufacturing schedules to meet revenue targets. The incumbent will evalaute materials requirements to support the site's financial targets. This position requires excellent communication and analytical skills and works closely with all departments to meet business goals and best-in-class customer service levels. The incumbent will work closely with Manufacturing Operations, Supply Chain, Quality Assurance, Customer Service, Engineering and Facilities, and Information Technology to achieve the client’s timeline and department objectives.

**Your Profile:**

· Develops, finalizes, and communicates the material requirements plan for the site that meets customer demand on timely availability.

· Plans, prepares, and controls material availability to ensure a flow of approved materials meeting production requirements considering storage conditions and capacity.

· Create Process Orders in our ERP System to support the materials plan.

· Ensures on time deliveries by follow up and working with brokers and freight forwarders as needed.

· Advises management of material events that can potential disrupt the production plans.

· Schedules timely delivery of materials; evaluates material supply and demand; establishes ROP/ROQs based on forecasts and storage capacity.

· Coordinates interdepartmental activities with quality assurance, manufacturing, facilities and supply chain management.

· Schedules and expedites the approval of materials to support the production schedule and other Project activities.

· Follow established departmental policies, procedures, and objectives. Supports continuous quality improvement objectives, and safety regulations.

· Development and maintenance of SCM KPIs (inventory turns, schedule adherence, obsolete inventory, etc.).

· Maintains and reports key site metrics and KPI presentations to key stakeholders and corporate leaders as required.

· Measure supplier delivery performance and address opportunities.

· Responsible for supporting the training of other teammates as needed.

· Responsible for Change Control management activities related to Supply Chain such as: new source of supplies, change in specifications, vendor change, others.

· Support the creation and maintenance of Master data and BOM's.

· In addition, the jobholder is obliged to carry out other tasks as may be instructed by his/her superior - individual tasks which by their nature belong to his activities or result from operational requirements.

· Inform their superior about any extraordinary events.

**Required Knowledge, Skills, and Abilities**

· Self-starter, organized and detail-oriented.

· Strong problem solving, data analysis and computer systems skills.

· Good business acumen.

· Good communication skills, both verbal and written.

· Multi-tasking and excellent time management skills.

**Required Education and Experience**

· Bachelor’s degree with 5+ years’ experience in production scheduling, demand or MRP within a regulated manufacturing environment (cGMP, FDA, ISO).

· Experience inputting and retrieving data in ERP or MRP systems. SAP or Oracle preferred.

· Strong understanding of material requirement concepts.

· APICS and Lean Six Sigma certifications a plus.

· Experience working in a dynamic high-paced environment.

· Excel experienced. -  **_Be prepared to demonstrate proficiency in Excel during the interview process._**

**Target Salary Range: $110,000 - $125,000 annually**

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision, Life
- Voluntary Accident, Hospital, Pet
- 401K
- Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Quality Assurance Operations Supervisor, Pharmaceutical Manufacturing - 2nd Shift

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Lead Quality Where It Matters Most

If you've built your career in pharmaceutical manufacturing and enjoy leading people, developing teams, solving problems in real time, and being where the action happens, we'd love to meet you.

As the QA Operations Supervisor, 2nd Shift, you'll lead a team of QA professionals supporting sterile and aseptic manufacturing operations while serving as the primary Quality leader on the production floor. Working closely with Manufacturing, Validation, Engineering, and Microbiology, you'll help ensure products are manufactured safely, consistently, and in compliance with cGMP requirements. Every decision you make helps support our clients and the patients who rely on the treatments we produce.

This is a hands-on, onsite leadership role for someone who thrives in a fast-paced GMP environment, enjoys coaching and developing others, and takes pride in building a strong culture of quality, compliance, and patient focus. You'll spend much of your time on the manufacturing floor partnering with Operations, supporting production activities, and providing real-time quality oversight where it matters most.

**Your Profile:**

**Key Responsibilities**

**Lead & Develop the Team**

- Supervise, mentor, and develop a team of QA Technicians and QA Associates supporting second-shift operations.
- Manage shift staffing, work assignments, priorities, and shift handoffs.
- Provide coaching and leadership that strengthens quality culture, accountability, and team performance.
- Foster a collaborative environment focused on continuous improvement and operational excellence.

**Manufacturing Quality Oversight**

- Serve as the primary QA leader supporting second-shift sterile and aseptic manufacturing operations.
- Provide real-time quality oversight for formulation, compounding, filling, visual inspection, and packaging activities.
- Perform in-process verifications, line clearances, operational observations, and batch record reviews.
- Maintain an active presence on the manufacturing floor to ensure compliance with cGMP requirements, SOPs, data integrity principles, and sterility assurance practices.
- Observe aseptic techniques, gowning practices, and critical interventions to support product quality and patient safety.

**Compliance & Continuous Improvement**

- Support investigations, deviations, CAPAs, and root cause analysis activities.
- Evaluate quality events and partner cross-functionally to resolve issues and drive sustainable improvements.
- Promote Right-First-Time documentation practices and ALCOA+ data integrity principles.
- Monitor quality performance and identify opportunities to strengthen compliance and operational effectiveness.
- Support a culture of continuous inspection readiness.

**Audit & Regulatory Support**

- Serve as a Quality representative during client audits, customer visits, and regulatory inspections.
- Partner with Manufacturing, Engineering, Validation, Microbiology, and Quality Systems teams to maintain compliance and support operational excellence.

**Required Qualifications**

- Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific discipline.
- 4-6 years of experience in Quality Assurance, Quality Operations, or Manufacturing within pharmaceutical, biotechnology, or other GMP-regulated environments.
- Demonstrated supervisory, team lead, or people leadership experience.
- Strong understanding of cGMP requirements, FDA regulations, and quality systems.
- Excellent communication, coaching, problem-solving, and decision-making skills.
- Proven ability to make sound, risk-based quality decisions in a fast-paced manufacturing environment.

**Preferred Qualifications**

- Experience supporting sterile and aseptic manufacturing operations.
- Experience working in a pharmaceutical CDMO environment.
- Knowledge of EU GMP and Annex 1 requirements.
- Experience working within Grade A-D cleanroom environments.
- Familiarity with TrackWise, SAP, LIMS, or other electronic quality systems.
- Experience supporting client audits, customer visits, and regulatory inspections.

**Why Join Us?**

✔ Lead and develop a team of Quality professionals supporting sterile manufacturing operations

✔ Serve as the primary Quality leader for a critical production shift

✔ Join a growing pharmaceutical CDMO committed to quality, innovation, and continuous improvement

✔ Partner closely with Manufacturing, Engineering, Validation, Microbiology, and Site Leadership

✔ Gain valuable exposure to client programs, regulatory inspections, and complex sterile manufacturing operations

✔ Make a direct impact on product quality, compliance, operational performance, and patient safety every day

**Schedule**

**Onsite leading the 2nd Shift Team: 2:00 PM - 10:30 PM**

**Compensation**

**Target Salary Range: $90,000 - $110,000 annually**

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Apply today and bring your Quality leadership expertise to a team where your impact can be seen in every shift, every batch, and every treatment we help deliver to patients.**

**Your Benefits:**

- Medical, Dental, Vision, Life
- Voluntary Accident, Hospital, Pet
- 401K
- Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Manufacturing Engineer II (Process Expert)

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Are you a pharmaceutical manufacturing engineer who thrives on solving complex technical challenges, improving processes, and driving operational excellence in a GMP environment? Join our growing CDMO team and play a critical role in supporting the production of therapies that make a meaningful difference in patients' lives.

As a Manufacturing Engineer II (Process Expert), you will serve as a key technical resource for production processes and manufacturing instrumentation, driving process optimization, equipment qualification, investigations, technology transfers, and continuous improvement initiatives across API, formulation, aseptic fill-finish, inspection, and packaging operations.

**Your Profile:**

**What You'll Do**

- Provide technical support for GMP pharmaceutical manufacturing operations.
- Own and maintain critical manufacturing documentation, including SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.
- Lead or support equipment qualification activities (IQ/OQ/PQ), process validations, and continuous improvement projects.
- Serve as the technical owner for production instrumentation, including calibration, preventive maintenance, troubleshooting, requalification, and repair coordination.
- Lead investigations, root cause analyses, and corrective actions related to manufacturing events.
- Partner cross-functionally with Manufacturing, Quality, Engineering, and other stakeholders to ensure efficient, compliant, and reliable operations.
- Support process optimization, implementation of new technologies, and introduction of new products.
- Maintain inspection readiness and ensure compliance with GMP, FDA, safety, and environmental requirements.
- Provide technical guidance and training to manufacturing personnel.
- Support manufacturing operations directly as business needs require.

**Qualifications**

Required

- Bachelor's degree in Engineering, Biological Sciences, or a related technical discipline.
- 3+ years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing operations in a GMP-regulated environment.
- Experience qualifying equipment and manufacturing processes in a regulated manufacturing environment.
- Strong technical writing, data analysis, troubleshooting, and problem-solving skills.
- Working knowledge of GMP regulations, quality systems, and data integrity requirements.
- Demonstrated ability to manage multiple priorities in a fast-paced manufacturing environment.
- Strong communication and collaboration skills with the ability to influence and work effectively across cross-functional teams.

Preferred

- Experience with aseptic processing and fill-finish operations, including equipment preparation, formulation, sterile filtration, and filling.
- Experience supporting API manufacturing, sterile manufacturing, or commercial pharmaceutical production.
- Prior aseptic fill-finish experience is preferred and will provide a strong foundation for success in this role due to the cross-functional support provided across sterile manufacturing operations.

**Work Environment**

- Up to 50% of time spent supporting manufacturing operations on the production floor.
- Ability to safely lift, push, or pull materials and equipment up to 50 pounds, with or without reasonable accommodation.
- Ability to work in GMP manufacturing environments, including **ISO 5 through ISO 8 classified cleanrooms**, while wearing required gowning and PPE, including safety glasses, masks, gloves, hair coverings, scrubs, lab coats, and Tyvek suits.
- This position supports a **24-hour pharmaceutical manufacturing operation** and requires close partnership with production teams across manufacturing schedules.

**Why Join Us?**

This is an opportunity to broaden your expertise across the pharmaceutical manufacturing lifecycle while taking ownership of critical processes, equipment, and improvement initiatives in a growing CDMO environment. You'll gain exposure to API production, aseptic fill-finish manufacturing, process validation, continuous improvement, and cross-functional project leadership, all while contributing to the delivery of therapies that improve patients' lives.

**Compensation**

**Target Salary Range: $105,000 - $120,000**

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision
- Flexible Spending & HSA Options
- Life Insurance, Short & Long Term Disability
- Pet Insurance
- Generous PTO, Sick & Holiday Time Off
- 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Sanofi US

2027 Spring Co Op Site Management Operations

**Job Title:**  *2027 Spring Co-op Site Management Operations*

- **Grade:**  *Co-op*
- **Location:**  *Waltham, MA*
- **Duration:**  *4 to 6 months*

**About the Job**

Looking to launch your career at thecutting edgeof healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As**Spring Co-op**in our**Biologics Drug Product Development Group,** youll support the US Vaccine R&D Site Operations team. In this role, you will work directly alongside Site Management Operations Leads to assist with day-to-day site activities, operational initiatives, and cross-functional projects across our US R&D facilities. This is an excellent opportunity for students pursuing careers in pharmaceutical/biotech operations, life sciences, engineering, or related fields to gain hands-on experience in a dynamic, GxP-regulated environment.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, youll be empowered to learn, ask questions, and bring your ideas to life all while supported by inspiring mentors and collaborative teams.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

Operational Support:

- Assist Site Management Operations Leads with tracking and coordinating ongoing site activities, action items, and deliverables.
- Support the preparation and maintenance of site operational dashboards, metrics, and KPI reports.
- Help monitor and follow up on open action items, corrective actions, and site commitments to ensure timely closure.

Data Analysis & Reporting:

- Collect, compile, and analyze operational data to identify trends, gaps, and opportunities for improvement.
- Prepare summaries, presentations, and reports for site leadership and cross-functional stakeholders.
- Support the development and maintenance of tracking tools (Excel, SharePoint, Power BI, or equivalent platforms).

Process Documentation:

- Assist in drafting, reviewing, and updating Standard Operating Procedures (SOPs), work instructions, and process maps.

Project Coordination:

- Provide coordination support for site improvement initiatives, capital projects, and operational change management activities.
- Track project milestones, timelines, and resource needs; flag risks or delays to Operations Leads.
- Assist in preparing project charters, status updates, and stakeholder communications.

Facilities & Equipment Group Support:

- Assist with equipment maintenance tracking and scheduling, including coordination of planned and corrective maintenance activities.
- Support facility maintenance coordination by helping to organize work orders, maintenance requests, and follow-up actions.
- Help maintain equipment inventory and asset management records, ensuring accuracy and completeness of asset databases.
- Assist with facility compliance documentation, including calibration records, equipment qualification documentation, and regulatory readiness materials.
- Support preventive maintenance (PM) programs by tracking PM schedules, monitoring completion rates, and escalating overdue items to the Facilities and Equipment team.

Cross-Functional Collaboration:

- Participate in cross-functional meetings with R&D, Engineering, Facilities, Supply Chain, and Regulatory Affairs teams.
- Serve as a liaison for information gathering and communication between site functions and Operations Leads.
- Support the planning and execution of site events, town halls, and operational reviews.

**About You**

**Basic Qualifications:**

- Currently enrolled in an accredited bachelor's or master's degree program in one of the following fields: Life Sciences (Biology, Microbiology, Biochemistry, or related)/ Chemical, Biochemical, or ingineering/ Pharmaceutical Sciences/ Operations Management, Supply Chain, or Business Administration/ Environmental Health & Safety or related discipline.
- Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the Internal requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
- Must be enrolled in an accredited college or university throughout the duration of the co-op/internship.
- Must be able to relocate to the office location and work 40hrs/week, Monday to Friday for the full duration of the co-op/internship.

**PreferredQualifications:**

- Strong organizational skills with the ability to manage multiple priorities simultaneously.
- Proficiency in Microsoft Office Suite (Excel, PowerBI/data visualization tools, PowerPoint, Word, Outlook); SharePoint experience a plus.
- Excellent written and verbal communication skills.
- Analytical mindset with attention to detail and data accuracy.
- Ability to work both independently and collaboratively in a team environment.
- Demonstrated ability to maintain confidentiality and handle sensitive information professionally.
- Prior internship, co-op, or research experience in a pharmaceutical, biotech, or regulated manufacturing environment.
- Experience with data visualization tools (Power BI, Tableau) or project management platforms (Smartsheet, MS Project).
- Knowledge of Lean, Six Sigma, or continuous improvement methodologies.

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
- Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
- Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.

**Compensation**

The salary range for this position is **$27.00 - $47.00**hourly. All compensation will be determined commensurate with demonstrated experience.

\#LI-Onsite

\#vhd

null

Massachusetts

Novo Nordisk

Process Engineer (Wash and Sterilization/Formulation)

**About the Department**

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including **14 paid holidays**

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Support development and install of new equipment and process for our aseptic and finished production areas to meet future business and regulatory requirements thru the following activities: Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus and Develop Standards for new equipment / processes.

**Relationships**

Reports to Manager, Technical Support.

**Essential Functions**

- Support technical development of Maintenance Technicians
- Support development of new production equipment and processes
- Lead projects to improve or enhance the production line upon install
- Support event response activities
- Maintain standards for procedures & maintenance plans
- Support DFP global collaboration initiatives.

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

**Qualifications**

- Bachelor's Degree in Engineering/related field or Equivalent (experience + education) required
- Minimum 3 years engineering experience in Maintenance, Design, Process Improvement; cLEAN® 1-Star preferred preferred
- Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA) a plus
- Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Insmed Incorporated

Director, Medical Safety

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Director, Medical Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll oversee a team of Pharmacovigilance (PV) Scientists responsible for signal detection, risk management, aggregate safety reporting, and clinical trial safety support and ensure the delivery of high-quality safety surveillance activities throughout the product lifecycle while maintaining compliance with global pharmacovigilance regulations and company procedures. You will also serve as a strategic partner to Medical Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, and Quality Assurance to ensure timely identification, assessment, and communication of product safety risks.

**What You'll Do:**

In this role, you’ll have the opportunity to lead, mentor, and develop a team of PV Scientists. You’ll also:

- Allocate resources across products and development programs to ensure timely execution of safety deliverables. Foster a culture of scientific excellence, collaboration, continuous improvement, and regulatory compliance.
- Provide scientific oversight of routine and ad hoc signal detection activities for investigational and marketed products. Ensure timely identification, evaluation, documentation, and communication of emerging safety signals. Review and approve signal evaluations and support safety governance activities.
- Lead the preparation, maintenance, and lifecycle management of core Risk Management Plans (RMPs) and associated safety documents. Support implementation and evaluation of risk minimization measures.
- Ensure consistency between RMPs, Core Safety Information, Investigator's Brochures, and product labeling.
- Oversee preparation and scientific quality of aggregate safety reports
- Provide strategic guidance on benefit-risk assessments and safety conclusions.
- Provide pharmacovigilance support to clinical development programs from First-in-Human through post-marketing. Partner with Medical Safety Physicians to ensure consistent medical and scientific evaluation of safety data. Collaborate with Regulatory Affairs to support regulatory submissions and responses.
- Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, ICH, and other applicable health authority requirements. Support regulatory inspections and internal/external audits. Interface with Quality Assurance regarding inspections, audits, CAPAs, and compliance initiatives.
- Lead the evaluation, implementation, and continuous optimization of AI-enabled tools for signal detection, aggregate reporting, literature surveillance, case review, and other pharmacovigilance activities. Identify opportunities to streamline workflows, improve data quality, and increase operational productivity while maintaining regulatory compliance and scientific integrity.

**Who You Are:**

You have a Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline along with 10 years of experience in within the pharma/biotech industry as well as minimum of 5 years of direct people management experience leading PV Scientists or Medical Safety professionals

You are or you also have:

- Demonstrated experience supporting both clinical development and post-marketing pharmacovigilance activities
- Extensive experience in signal detection and signal management. Experience with safety databases (e.g., Argus, ARISg) and safety analytics tools is preferred.
- Strong understanding of benefit-risk assessment methodologies. Exceptional experience authoring and managing Risk Management Plans (RMPs), aRMM and REM.
- Significant experience preparing and overseeing aggregate safety reports (DSURs, PSURs/PBRERs, Annual Reports).
- Experience supporting clinical studies throughout the product development lifecycle.
- Thorough knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulations
- Excellent leadership with strong scientific and analytical skills. Strategic thinker with strong project management skills.
- Ability to influence cross-functional stakeholders and PV senior leadership. Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.
- Demonstrated commitment to quality, compliance, and continuous improvement exceptional written and verbal communication skills
- Strong understanding of AI, automation, and advanced analytics applications within pharmacovigilance and drug safety. Proven ability to evaluate and implement innovative technologies that improve operational efficiency, data quality, and regulatory compliance.

**Nice to Have (but not required):**

- Advanced scientific degree
- Experience in pulmonary disease, rare diseases and gene therapy
- Experience participating in regulatory inspections and audits
- Experience leading global pharmacovigilance initiatives
- Familiarity with safety data visualization and signal detection methodologies
- Experience working in a matrixed global organization

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

Minimal travel expected – up to 15%

\#LI-Remote

\#LI-JK

**Pay Range:**

$185,000.00-252,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Nationwide

Summer Intern - Development Operations

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Summer Intern - Development Operations on the Clinical Development Team to help us expand what’s possible for patients with serious diseases.

The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical industry—it’s a chance to make a real impact. Over the course of the summer, you’ll gain hands-on experience, contribute to meaningful team projects, and learn directly from skilled professionals who are invested in your growth.

Our 2027 Summer Intern program is a full-time (40 hours per week), 12-week, paid internship. The internship may present opportunities for rotational assignments within the function, and the intern will be assigned goals and objectives that will support the strategic business plan of the company.

**What You'll Do:**

In this role, you’ll have the opportunity to gain hands-on experience in a corporate environment in the pharmaceutical industry, receive mentoring from highly skilled professionals, and work on dynamic team projects.

You’ll also:

- Assess how Development Operations (Dev Ops) teams currently use shared tools and identify opportunities to work more efficiently — for example, optimizing Microsoft Teams for communication and project coordination, or building out structured SharePoint sites for centralized document management, cross-team visibility, and streamlined workflows.
- Rotate between the four Dev Ops groups (responsibilities may change based on the group you are supporting at a given time):
  - Clinical Trial Operations
  - Clinical Business Operations
  - Clinical Program Optimization and Innovation
  - Medical Writing and Trial Transparency & Disclosure
- Shadow individuals in various roles within Dev Ops (e.g., Clinical Trial Manager, Clinical Trial Assistant, Trial Master File Specialist, Clinical Finance Manager, Medical Writer, Trial Transparency and Disclosure Manager, Vendor Alliance Manager, Clinical Process Manager)
- Support special projects and work group initiatives with a goal to enhance Dev Ops ability to conduct efficient, high-quality clinical trials
- Review trial related documents, spreadsheets, and systems to assess the accuracy and completeness of information e.g., clinical site generated documents, Trial Master Files, financial spreadsheets, protocols

**Who You Are:**

You are a current student working on a Bachelor’s, Master’s, or advanced level degree in Biology, Chemistry, Pharmacology, Nursing, or Accounting.

You are or you have:

- Interested in pursuing a career in the pharmaceutical industry
- High level understanding of what clinical trials are and their purpose
- Excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Ability to interact successfully in a dynamic and culturally diverse workplace.

**Pay Range:**

$20.00-35.00 Hourly

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. Our internship program reflects that commitment by supporting how you learn, grow, and show up each day while contributing to work that matters.

Our internship offerings include:

- Paid company holidays
- Hands-on learning in real-world projects
- Networking opportunities with leaders and social events with your peers
- Mentorship and professional development
- A final presentation to celebrate your contributions
- Access to office amenities for those who are not remote

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

[*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

New Jersey

Amgen

Process Development Associate

**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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

**Process Development Associate**

**What you will do**

Lets do this. Lets change the world. In this vital role you will perform sample preparation, analytical testing, method development, and characterization using biophysical and spectroscopic techniques, including but not limited to Infrared (IR) spectroscopy, Circular Dichroism (CD) spectroscopy, UV-visible spectroscopy, and Differential Scanning Calorimetry (DSC) for thermal stability analysis. These activities will support product and process characterization and regulatory submissions. Experience with high-performance liquid chromatography (HPLC) for protein analysis is desired.

The associate will characterize higher-order structure (HOS) and aggregation-related attributes of biologics in support of product characterization, comparability and similarity studies, technology development, and non-routine investigations. Additional responsibilities will include sample preparation, complex data analysis and interpretation, trouble shooting, generation of technical reports and presentations, and development of acceptance criteria to support process development and comparability/similarity studies.

The position requires strong scientific and analytical skills, the ability to work collaboratively with scientists across multidisciplinary and cross-functional teams, and the flexibility to adapt to changing priorities in a fast-paced environment.

**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:**

Bachelors degree

OR

Associates degree and 2 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience

OR

High school diploma / GED and 4 years of Chemistry, Biochemistry, Biotechnology, Physics, or related experience

**Preferred Qualifications:**

- Two or more years of experience directly related to the biophysical characterization of proteins, including hands-on experience with spectroscopic and biophysical techniques such as IR, CD, UV-visible spectroscopy, and DSC for thermal stability analysis.
- Hands-on experience with HPLC systems for the separation and characterization of proteins.
- Strong laboratory and analytical skills, including routine testing as well as the design and execution of scientific experiments, data analysis, interpretation of results, and maintenance of accurate laboratory records.
- Experience developing, qualifying, and/or validating analytical methods, analyzing and interpreting complex data, and establishing acceptance criteria to support product comparability and similarity studies.
- Demonstrated ability to collaborate effectively with scientists across multidisciplinary and cross-functional teams.
- Strong technical communication skills, including preparation of technical reports, scientific presentations, and documentation supporting regulatory activities.
- Ability to work independently, manage multiple priorities, and adapt effectively to evolving project needs and timelines.

**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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Senior Manager Manufacturing Night Shift Operations Performance & Integration

**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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

**Night Senior Manager Manufacturing Night Operations Performance & Integration (Continuous Improvement)**

**What you will do**

Lets do this. Lets change the world. In this vital role the Night Shift Senior Manager of Manufacturing at Amgen is responsible for establishing and sustaining a strong night-shift operating system that provides off-shift operational direction for Commercial Operations and for Project based Commissioning and Qualification (C&Q) coverage, ensuring the right cross-functional resources are engaged, issues are escalated and resolved with urgency, and manufacturing performance is actively managed across the shift.

Partners with Engineering, Automation, QA, Technology, Maintenance, Supply Chain/Warehouse, Capital Projects.

**Responsibilities**

- Serve as the senior Manufacturing integration point across night-shift operations during significant operational events.
- Establish and sustain the night-shift Tier structure, operating cadence, escalation model, and performance-management routines.
- Coordinate Manufacturing, Quality Assurance, Engineering, Automation, Maintenance, Supply Chain/Warehouse, and other site resources required to maintain safe, compliant, and reliable operations.
- Drive escalation of significant resource constraints, technical barriers, competing priorities, or unresolved operational issues to appropriate site or functional leadership.
- Monitor overall night-shift Manufacturing performance across production lines, including downtime, OEE, schedule attainment, recurring interruptions, escalation effectiveness, and chronic losses.
- Partner with the daytime Manufacturing Senior Manager, Continuous Improvement Senior Manager and MFG process Support Senior Manager to identify, prioritize, and execute improvement opportunities across off-shift, including 5S, visual management, standard work, workplace organization, waste reduction, flow improvement, and training operating discipline.
- Provide coaching and situational leadership to Front Line Managers during complex operational events

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years in GMP manufacturing, process development, or combination device, and/or manufacturing focused six sigma lean operational excellence.

OR

Masters degree and 6 years in GMP manufacturing, process development, or combination device, and/or manufacturing focused six sigma lean operational excellence.

OR

Bachelors degree and 8 years in GMP manufacturing, process development, or combination device, and/or manufacturing focused six sigma lean operational excellence.

OR

Associates degree and 10 years in GMP manufacturing, process development, or combination device, and/or manufacturing focused six sigma lean operational excellence.

OR

High school diploma / GED and 12 years in GMP manufacturing, process development, or combination device, and/or manufacturing focused six sigma lean operational excellence.

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 or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**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 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 & vision coverage, and life & disability insurance
- 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.

**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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Ohio

Senior Manager, Construction Contractor Safety

**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, Construction Contractor Safety**

**What you will do**

Lets do this. Lets change the world. In this vital role you under minimal direction, support the implementation, governance, standards, training, and performance processes that comprise the Amgen Construction Contractor Safety Program. The role provides technical leadership across capital projects, promotes consistent contractor and subcontractor compliance, and partners with project leaders, EHS, engineering, and external companies to manage complex construction safety risks.

Key Responsibilities:

- Program Leadership and Governance
- Lead the development, implementation, and continuous improvement of construction contractor safety program elements, modules, systems, standards, and training.
- Participate as a member of capital project leadership teams and advise management on project safety performance, priorities, operations, and scheduling considerations.
- Ensure effective governance processes for tracking safety performance across capital projects through the collection, review, and interpretation of meaningful metrics.
- Use safety metrics and performance trends to recommend and implement changes that refocus safety efforts and improve outcomes.
- Identify and implement appropriate technology solutions, including emerging tools such as artificial intelligence, to improve the efficiency and effectiveness of construction safety management.
- Contractor and Project Safety Management
- Monitor contractor and subcontractor compliance with applicable regional safety regulations, construction and general industry safety standards, and company requirements.
- Manage EHS prequalification and, where applicable, requalification of design and construction contractors and subcontractors by confirming adequate training, knowledge, experience, and resources to meet their EHS obligations.
- Review contractor project-specific safety plans and verify that appropriate systems and resources are in place to support safe project execution.
- Ensure contractor and subcontractor orientation and training are provided to impacted personnel and ensure project engineers and managers receive training on company expectations for construction safety management.
- Coordinate with appointed project supervisors and other designated safety roles, providing the information and cooperation necessary for them to fulfill their health and safety obligations.
- Manage designated construction safety service-provider or project-supervisor contracts, as applicable to the site or region.
- Risk Assessment, Assurance, and Compliance
- Ensure adequate systems and resources are available to review and approve construction activity risk assessments and method statements, including STAs, and JHAs, in a timely and compliant manner.
- Facilitate safety performance reviews, field inspections, and audits, and ensure identified non-conformances are documented, communicated, tracked, and addressed.
- Monitor and prioritize the safety agenda based on project schedules, project load, risk profile, and emerging conditions.
- Compile, analyze, and report safety statistics and performance information to management as required.
- Incident Management
- Participate in incident investigations, as necessary, and support the communication of root cause analysis, corrective actions, and lessons learned.
- Escalate Incidents based on the incident management SOP.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The safety professional we seek will possess these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years of Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline experience

OR

Masters degree and 6 years of Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline experience

OR

Bachelors degree and 8 years of Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline experience

OR

Associates degree and 10 years of Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline experience

OR

High school diploma / GED and 12 years of Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline experience

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 or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- 10 or more years of construction safety experience supporting large capital projects.
- Demonstrated knowledge and application of safety regulations and construction technical standards, principles, and techniques.
- Demonstrated ability to solve complex safety problems and develop practical, compliant solutions.
- Ability to work independently under minimal direction and determine an appropriate approach to assigned responsibilities.
- Ability to travel approximately 50%, including regional, domestic, or international travel based on role location and business needs.
- Bachelor's degree in Environmental Health and Safety, Occupational Safety, Engineering, or a related EHS discipline.
- Experience managing construction safety in the pharmaceutical or biopharmaceutical industry.
- Experience supporting contractor safety governance across multiple capital projects, sites, or regions.
- Experience using technology and data analytics to strengthen construction safety performance.
- Professional safety certification such as CSP, CIH or equivalent.

**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.

**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.

AbbVie

Senior Clinical Manufacturing Lead II

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Lead production teams to produce high quality solid dosage form clinical supplies utilizing state-of-the-art technologies. This requires interaction with formulation colleagues to develop reliable and efficient manufacturing processes. These processes are then translated into executable manufacturing instructions when followed appropriately result in the efficient production of GMP compliant clinical supplies.

- Operations: Leads manufacturing activities, including the preparation and close out of batch records; Ensures the batch record documentation is executed with minimal errors; Starts and completes manufacturing activities on time, according to the established schedule. Leads discussions with QA on quality related topics associated with manufacturing and documentation. Manages X-step content to ensure PI sheets are accurate.
- Supervision: May supervise the pilot plant technicians including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews. May provide similar supervision to Clinical Manufacturing Lead I and/or II.
- Formulation Development: Collaborates with formulators on formulation development and research activities occurring in the pilot plant. Provides key pilot plant capabilities insight on these activities.
- Technical Support: Possess detailed knowledge of pilot plant equipment and processing capabilities. Provide technical guidance to manufacturing personnel. Provides leadership with trouble-shooting and identifies solutions to issues that arise during manufacturing; Provides strategic product development and technology improvement activities; actively participates in functional area improvement initiatives.
- Compliance: Understands and follows cGMP requirements, established policies; Writes and follows procedures and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
- Project Coordination: Works with the CMC team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
- Communication: Records, tabulates and reports results within the group or team using the necessary tools (Reports, memos, presentations, spreadsheets, notebooks, etc.); Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicates concerns and participate in discussions.
- Leadership: Direct activities of manufacturing technicians in a matrix environment.

Qualifications

- B.S. in Chemistry, Biology or related scientific area or equivalent and relative work experience.
- 10+ years experience in operations, R&D and/or related area
- Experience in a cGMP environment is highly desired

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Strategic Site Partner

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The success of CDO depends on our ability to develop a holistic strategy and global network of exceptional PIs and institutions in order to accelerate delivery of our pipeline. In an increasingly competitive landscape, strategic partnerships are critical to maximizing the solid tumor and hematology pipelines. The **Strategic Site Partner (SSP)**  serves as a key driver and main point of contact for our key partner sites and is passionate about establishing and strengthening strategic partnerships cross-functionally with key clinical sites in order to unlock operational potential and build strong, longitudinal relationships.

The **SSP** is responsible for adopting relationship management principles and critically thinking to better understand all business dimensions to impact and drive operational efficiencies in the conduct of AbbVie’s pipeline. In addition, they will align expectations between AbbVie and investigative site stakeholders proactively identifying opportunities to drive clinical trial accelerations and efficiencies at the study and/or program level.

The **SSP** is responsible for engaging internal leaders at all levels to maximally leverage aligned collaborations cross functionally with a goal of enabling alliances to deliver results consistent with strategic goals and to enhance AbbVie’s relationships to secure the company's reputation as a Partner of Choice.

The **Strategic Site Partner** reports to the **Director, Strategic Site Partnership**.

- Provides input and develop the site-specific engagement strategy for assigned sites.
- Builds and manages relationships with assigned investigative sites through a white-glove service. approach while meeting with Institution Leadership, Principal Investigator and clinical site staff both on-site and remotely.
- Raises the bar to proactively anticipate a site’s needs and drives timely mitigation strategies.
- Maintains a solution-oriented mindset to facilitate resolution of complex operational issues.
- Remains informed of best practices and innovations that have resulted in efficiencies across the business and/or industry and put actions in place that support the organization in removing identified barriers.
- Identifies areas to drive efficiencies and/or accelerate clinical trial execution. Drives consistency across studies and programs.
- Oversees overall performance metrics across studies, conducts review of site’s operations for quality. Evaluates and addresses aligned KPIs with site.
- Reviews and shares upcoming study forecasts and current clinical study needs regarding the studies in which the site is participating for strategic resource planning with the site.
- Reviews interests and study capacity with site and communicates back to internal AbbVie stakeholders.
- Identifies and recommends opportunities for internal improvements, implements improvements to maximize process efficiency/accelerate trial delivery at the site.
- Reviews cross business portfolio forecasts of studies to provide direction for investigative sites.
- Escalates risk to relevant stakeholders, resolves identified operational issues that span across studies/programs.
- Seeks to align AbbVie and the site's operations to execute clinical trials efficiently.
- Provides operational and holistic focus on site needs to ensure optimal delivery of clinical trials.
- Generates, expands and enhances operational effectiveness and consistency within AbbVie and at the investigative sites.
- Works closely with internal stakeholders to facilitate, manage and oversee the scientific and operational relationships cross functionally across AbbVie to ensure a productive working environment.
- Provides cross-functional partners an open and continuous channel of communication to ensure investigative sites perspectives are heard and well represented internally.

Qualifications

- Bachelors or higher degree required, degree in health care or scientific field preferred.
- Minimum of 10 years applicable work experience in clinical research demonstrating a high level of core, technical, and leadership competencies through driving strategy. Prior relationship management experience preferred.
- Broad understanding of global pharmaceutical and biotech industries with a solid understanding of drug discovery and development processes. Expertise in drug development, operations, strategic and tactical planning,
- Strong communication skills with advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
- Strong collaboration and interpersonal skills; ability to establish good working relationships with external and internal stakeholders as well as management.
- Seamless collaborator with demonstrated ability to influence without authority – easily builds relationships across locations and gains cross-functional alignment.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Demonstrated leadership, influence skills, creativity, problem solving and ability to manage complexity in addressing issues.
- Demonstration of success in a fast‐paced environment managing multiple priorities, comfortable to manage risk and ambiguity, changing course when needed.
- Must possess excellent oral and written communication skills.
- Ability to travel up approximately 10%-20% of the time for on-site partner engagements. Additional travel may be required.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Immunocore

VP, Global Commercial Supply Chain, Distribution & Trade

Vacancy Name

VP, Global Commercial Supply Chain, Distribution & Trade

Vacancy No

VN839

Employment Type

Full Time

Location of role

Dublin, Ireland or Abingdon, UK

Department

Commercial Supply Chain

Key Responsibilities

The incumbent is expected to use leading-edge, deep expertise across global commercial supply chain, distribution and trade operations to influence, champion and drive innovation, resilience and growth strategies.

The Vice President, Global Commercial Supply Chain, Distribution & Trade reports to the Senior Vice President of CMC and Supply Chain and is responsible for the strategic and operational leadership for the global commercial third-party logistics (3PL) supply chain, global distribution, market access and trade operations for Immunocore. Through strategic planning, and co-ordination of the management of external suppliers and 3PL providers, production of Finished Product (packaging and labelling), warehousing, artwork, serialization, inventory management, shelf-life management, global distribution to third-party specialty and wholesale distributors, shipping & customs, financial wholesaling, financial data management and regulatory compliance, ensuring the timely and cost-effective delivery of global commercial supplies to medical centres and patients. Working in partnership with Immunocore colleagues in CMC, Commercial Supply Chain, Regulatory, Quality Assurance, Clinical Operations, Medical Affairs and Commercial, as well as with external 3PL providers, distributors, and wholesalers providing market access and trade.

The role sets the tone for expert people leadership by promoting psychological safety, continuous learning, succession planning, talent development and fair management of escalated performance matters through appropriate process and due course of action.

Key Responsibilities:

• Responsible for the development, implementation, and strategic leadership for Immunocore global commercial supply chain planning and logistics. Ensuring the logistical, compliance and regulatory integrity of Supply Chain activities to enable progression of Immunocore Commercial activities.

• Leadership within the expanding Commercial Supply Chain operations, supporting KIMMTRAK and future Immunocore commercial products. Typically managing a small team of Immunocore employees and contractors with a commercial supply chain operational focus. This position is responsible for strategic leadership and oversight of the following functional Commercial Supply Chain areas:

o Management of external Suppliers and 3PL providers

o Manufacturing of Finished Product (Packaging and Labelling)

o Warehousing and Inventory Management

o Artwork

o Serialization

o Shelf-life management (in collaboration with the CMC Stability team)

o Global distribution to third-party specialty and wholesale distributors

o Shipping & Customs

o Management of Wholesale Distributors / Specialty Distributors

o Commercial Financial and Financial Data Management (Working with Finance)

o Commercial GDP Compliance (Working with Quality Assurance)

o Global distribution life-cycle management

• Working with CMC, Commercial Supply Chain, Regulatory, Quality Assurance, Finance, Clinical Operations, Medical Affairs and Commercial to provide supply chain processes that are robust, efficient, and cost effective, ensuring the timely and cost-effective delivery of commercial supplies to medical centres and patients.

• Develop supply chain options, facilitate decision-making, and communicate updated manufacturing and commercial supply plans to all impacted stakeholders.

• Fully conversant with philosophies and regulatory guidelines pertinent to Commercial Supply Chain. Contribute and manage the relevant commercial supply chain information included within regulatory submissions.

• Representation and leadership within Immunocore Program teams, providing Supply Chain strategic support and technical consultancy. Contribution is made through the evaluation, recommendation, and implementation of best practice.

• Develop Key Performance Indicators (KPIs) for the execution and tracking of Supply Chain activities.

• Collaborate with IT to develop and implement supply chain IT systems and tools for Supply Chain planning, execution, and analysis.

• Proactively identify, lead, and resolve Supply Chain problems/barriers. This behaviour requires lateral independent thinking and innovative generation of ideas and solutions, coupled with an awareness of the appropriate compliance and regulatory environment.

• Effective resource management and control of annual Commercial Supply Chain budgets. Plan, develop and deploy resources and budget plans and meet agreed spending targets.

Other

• Contribute to Immunocore governance bodies and Program teams to progress drug candidates through lead selection/optimization, preclinical development, clinical development and through to commercial life cycle management.

• Communicate effectively and transparently with functional heads within Research, Development and Commercial across the company.

• Facilitate a suitable Health & Safety working environment for employees.

• Work with QA to develop and maintain a fit-for-purpose Quality Management System for Supply Chain, suitable of supporting regulatory inspections.

• Supporting Wholesale Distribution Authorisation (WDA) compliance activities and must be trained and understand the requirements of Good Distribution Practices (GDP), as defined in Directive 2001/83/EC and various national legislations.

• Must have regular and continual training relevant to the role of Vice President, Global Commercial Supply Chain, Distribution, and Trade. Training will include specific aspects of product identification and avoidance of falsified medicines entering the commercial supply chain.

Supervisory Responsibility (If applicable):

• Typically manages a small team of Immunocore employees and contractors with a commercial supply chain operational focus; likely direct reports: 3. Oversees team capability, succession planning, development and performance management in line with Grade B1 leadership expectations

Education, Experience and Knowledge:

Essential Qualifications:

• BSc or MSc in business, supply chain operations or a related discipline.

• Minimum 15 years of progressive supply chain management and leadership experience.

Preferred Qualifications:

• PhD in a related discipline

Essential Experience

• Strong experience in commercial pharmaceutical or biotech supply chains, external supply management, ERP/MRP systems, supply planning, procurement and global distribution

• Line and team management experience

• Experience working with Contract Manufacturing/External Supply Management

• Experience with late stage/commercial pharmaceutical/biotech company supply chains

• Experience starting up new external Supply Chain organization, tools, and processes

• Strong background of working with ERP/MRP/Supply Chain systems and tools

• Management of supply to geographically diverse clinical centres

• Excellent supply chain analysis skills (e.g. modelling, “What If” analysis)

• Strong relationship building skills

Desirable Experience

• Contributed to CMC Module 3 regulatory sections

• Proven track record of line management and building a department

• Working knowledge of finance and budgeting

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Senior Production Technician

**Job Title**: Senior Production Technician

**Location:**  Swiftwater, PA

**Shift**: Off Shift

**About the job**

Sanofi is seeking an experienced production technician for the role of Senior production technician. This is an exciting opportunity for a candidate to develop leadership skills and is a crucial role in overseeing the production process, ensuring products are manufactured according to established specifications, schedules, and quality standards.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Ensuring that processes are always compliant with FDA regulations.
- Maintain and repair equipment and monitor software and hardware issues.
- Train and guide Personnel in proper work procedures, use of equipment, cGMPs, safe work techniques and SAP to assure timely signoffs and consistency in training.
- Maintains qualified trainer status.
- Identifying and preventing deviations and assisting in investigation and root cause analysis.
- Ensures operational areas are always staffed adequately and breaks are managed accordingly.
- Accountable for the completion of operations including Metasys and Lab watch, corresponding documentation, data entry, etc.
- Acts as Liaison for Production and Lead Technicians to dictate support.
- Works with Lead Technicians and managers to ensure continuous operation.
- Continues Development by completing at least one developmental class annually.
- Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR), and other assigned projects.
- Ensuring that quality documents like Batch Production Records (BPRs) and logbooks are completed accurately and on time.
- Ensuring documentation is completed accurately and in real-time is crucial for compliance and quality control.
- Preparing areas for the next shift helping to maintain smooth operations and efficiency.
- Responsibly use material in an efficient matter to reduce waste.
- Sharing improvement ideas, issues, concerns to team members along with providing solutions.
- Proactive in identifying and solving production issues to ensure smooth operations.
- Model and uphold HSEEn standards, ensuring compliance with all safety procedures.
- Report safety concerns, near misses, equipment issues, and environmental incidents promptly.
- Participate in safety meetings, walkthroughs, and improvement initiatives.
- Maintain a clean, organized, and safe work environment, performing necessary checks and inspections.
- Support continuous improvement by providing input on corrective and preventive actions.
- Follows effective procedures to ensure the production of safe and efficacious products.
- All other duties as assigned.

**About You**

**Required Qualifications:**

- HS or GED with 3+ yrs in cGMP or pharmaceutical experience
- Associates with 2 + yrs. in cGMP or pharmaceutical experience
- Bachelors with 1 + yr. in cGMP or pharmaceutical experience
- Good mechanical skills, computer skills and is detail oriented.
- Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
- Proficiency in at least but not limited to one area of operation or product line.
- Must be a qualified trainer in one or more areas.
- Must have access to systems in applicable buildings and processes which have these systems (SFD, PI, Metasys, Lab watch)

**Special Working Conditions:**

- Ability to lift up to 50 lbs.
- Ability to stand on average 8 hours per shift.
- Ability to gown and gain entry to manufacturing areas.
- Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled.
- May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need.
- May also include working in an aseptic processing area.

**Why Choose Us?**

- A rare opportunity to build operations from the ground up in a state-of-the-art aseptic facility
- Exposure to cutting-edge aseptic processing technology and next-generation manufacturing practices
- Career development and growth within a dynamic, expanding organization
- A collaborative, innovative work environment that values curiosity, digital thinking, and challenging the status quo.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Pennsylvania

2027 Spring Co-Op Downstream Process Development and Technologies, Framingham, MA

**Job Title:**  *2027 Spring Co-op Downstream Process Development and Technologies*

- **Grade:**  *Co-op*
- **Location:**  *Framingham, MA*
- **Duration:**  *6 months*

**About the Job**

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. We are seeking a highly motivated **Spring Co-op** to join our **Downstream Process Development and Technologies team**.

The 2027 Spring Co-Op will work in the downstream process development group of the drug substance function in Recombinant Mammalian Science, Analytics, and Technology (MSAT). The co-op will work in a laboratory setting on a project related to protein purification process characterization and/or protein drug substance stability. This position is 6 months on a full-time basis January 2027 June 2027.

The drug substance function within Recombinant Mammalian Science, Analytics, and Technology (MSAT) is the owner of Life Cycle Management (LCM) of DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with a continuous process platform. We are pursuing future innovations such as digital labs, factories of future and advanced analytics-based process understanding and control.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, youll be empowered to learn, ask questions, and bring your ideas to life all while supported by inspiring mentors and collaborative teams.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Work on an MSAT development project, to include execution of chromatography and filtration operations, protein stability studies, analytical testing, and data analysis.
- Collaborate with the MSAT project team; attend regular team meetings and share study progress and results.
- Participate in design and execution of experiments using small-scale models, analyze and interpret results, and recommend additional experiments.
- Author internal presentations, protocols, and technical reports, as applicable.

**About You**

**Basic Qualifications:**

- Currently pursuing a Bachelor's, Master's, or PhD in Chemical Engineering, Biochemistry, Biotechnology, or related disciplineat an accredited college or university with the expectation that you will complete your current degree by the Spring of 2028.
- Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
- Must be enrolled in an accredited college or university throughout the duration of the co-op/internship
- Must be able torelocateto the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship.

**Preferred Qualifications:**

- Experience in a biotechnology or pharmaceutical industry laboratory setting.
- Experience with downstream processes at lab, pilot, or production scale including chromatography (e.g. AKTA), tangential flow filtration, or nanofiltration.
- Knowledge in protein stability studies and routine protein analytical techniques.
- Strong technical writing and presentation skills.

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
- Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
- Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.

**Compensation**

The salary range for this position is **$35 -$57 USD** hourly. All compensation will be determined commensurate with demonstrated experience.

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2027 Spring Co op HSE Process Excellence Framingham MA

**Job Title:**  *2027 Spring Co-op HSE Process Excellence*

- **Grade:**  *Co-op*
- **Location:**  *Framingham, MA*
- **Duration:**  *6 months*

**About the Job**

Looking to launch your career at thecutting edgeof healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As**Spring Co-op**in our**HSE Process Excellence team**.

The HSE Intern/Co-op will support the Health, Safety & Environment (HSE) team in driving continuous improvement initiatives that enhance safety performance, reduce risk, and promote a strong safety culture across the site. This role sits at the intersection of HSE and Process Excellence, providing hands-on experience with operational improvement tools, training development, data analytics, and field-based safety initiatives.

Ready to grow your skills while helping shape the future of healthcare? At Sanofi, youll be empowered to Early Careers learn, ask questions, and bring your ideas to life all while supported by inspiring mentors and collaborative teams.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Support the implementation, monitoring, and maintenance of HSE programs, policies, and standards.
- Assist with incident investigations, root-cause analysis, and development of corrective/preventive actions.
- Conduct safety observations, risk assessments, and workplace inspections alongside HSE professionals.
- Participate in HSE champion meetings; assist in preparing materials and tracking action items.
- Help develop and deliver safety training content, toolbox talks, and awareness materials.
- Maintain HSE documentation, records, and dashboards to ensure compliance with internal and external requirements.

Process Excellence & Continuous Improvement

- Support process mapping, gap assessments, and workflow optimization within HSE activities.
- Contribute to Lean/Six Sigmastyle initiatives, including development of standard work and visual management tools specific to HSE.
- Collect, analyze, and present HSE performance data to identify trends and improvement opportunities.
- Assist in the creation or enhancement of digital tools, templates, and standardized processes for the HSE team.
- Partner with cross-functional groups (Operations, Quality, Facilities, etc.) to align HSE improvement projects with broader site objectives.

Engagement & Communications

- Help design communication materials to promote safety culture (posters, newsletters, campaigns, etc.).
- Participate in safety-related events, audits, and engagement activities.
- Support new program rollouts through data collection, document updates, and stakeholder coordination

**About You**

**Basic Qualifications:**

- Currently pursuing a bachelor's or master's degree in health and safety, Environment, Engineering, or related field at an accredited college or university with the expectation that you will complete your current degree by the Spring of in 2029.
- Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the Internal requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
- Must be enrolled in an accredited college or university throughout the duration of the co-op/internship.
- Must be able to relocate to the office location and work 40hrs/week, Monday to Friday for the full duration of the co-op/internship.

**PreferredQualifications:**

- Hands-on experience in real-world HSE program management and safety performance improvement.
- Opportunity to influence safety culture and participate in meaningful improvement projects.
- Mentorship from experienced HSE and Process Excellence professionals.
- Experience working cross-functionally in a fast-paced, high-impact environment.

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Stretch your skills through apprenticeships, internships, graduate programs, and international experiences that grow with you.
- Learn from inspiring mentors and collaborative teams while contributing to real projects that shape the future of healthcare.
- Build your future with access to the latest tools, digital innovation, and continuous learning that keep you ahead of the curve.

**Compensation**

The salary range for this position is **$35-$45 USD** hourly. All compensation will bedeterminedcommensuratewithdemonstratedexperience.

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\#vhd

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