Manufacturing & Production

AbbVie

TA Systems & Operations Specialist

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

**Purpose**

The TA Systems & Operations Specialist supports the execution, optimization, and continuous improvement of Talent Acquisition technology, workflows, automation, operational reporting, and service delivery.

This role partners with Talent Acquisition Operations, HRIT, Process Optimization, and other cross-functional teams to translate business needs into functional requirements, coordinate system enhancements, and identify opportunities to improve operational effectiveness.

A significant component of the position involves independently analyzing operational data, identifying trends and potential root causes, and translating findings into actionable insights and recommendations for Talent Acquisition and Operations & Innovation stakeholders.

The role combines analytical capability, systems knowledge, problem-solving, and strong communication skills to support data-driven decision-making and continuous improvement.

**Responsibilities**

1. TA Systems Execution & Enhancements | 25%

- Coordinate and support enhancements across Talent Acquisition technology platforms, including ServiceNow HRSD, SmartRecruiters, Workday, and related applications.
- Gather, document, and translate business needs into functional requirements and user stories for HRIT and technology partners.
- Maintain system enhancement requests and support backlog prioritization in partnership with TA Operations leadership.
- Coordinate user acceptance testing (UAT), defect tracking, implementation readiness, and post-launch validation.
- Identify opportunities to improve system functionality, user experience, workflow efficiency, and data accuracy.
- Support system integrations by documenting business requirements, investigating operational issues, and coordinating resolution with technical teams.

2. Operational Reporting, Analytics & Business Insights | 30%

- Develop, generate, and maintain recurring and ad hoc operational reports using ServiceNow, Excel, and other available reporting tools.
- Analyze ticket volumes, service-level performance, resolution trends, workflow effectiveness, system adoption, and operational performance.
- Investigate recurring issues, process inefficiencies, and emerging trends to identify potential root causes.
- Translate complex data into actionable business insights, identifying operational risks, improvement opportunities, and recommended actions.
- Develop dashboards, visualizations, and executive-ready presentations that communicate performance results and their operational implications.
- Summarize and present findings and recommendations to TA Operations, Operations & Innovation, and broader Talent Acquisition stakeholders.
- Partner with Process Optimization and operational teams to evaluate improvement opportunities and measure outcomes.
- Support workload forecasting, capacity analysis, and identification of emerging service-delivery trends.

3. Workflow Optimization & Automation | 20%

- Analyze existing Talent Acquisition workflows to identify manual activities, repetitive transactions, inefficiencies, and automation opportunities.
- Review operational trends to identify opportunities for workflow redesign, self-service, automation, and process simplification.
- Document current-state and future-state workflows, business rules, decision points, and functional requirements.
- Partner with HRIT and Process Optimization to support automation design, implementation, testing, and validation.
- Maintain a pipeline of identified workflow improvement and automation opportunities and provide recommendations on potential priorities.
- Track and report the operational impact of implemented enhancements, including efficiency gains, reduced manual effort, and improved user experience.

4. Knowledge Management & AI Enablement | 15%

- Support the ongoing maintenance, organization, and optimization of the ServiceNow knowledge management environment.
- Maintain knowledge content standards, article metadata, categorization, and documentation accuracy.
- Analyze operational trends and recurring inquiries to identify knowledge gaps and opportunities to strengthen self-service capabilities.
- Partner with subject matter experts to develop and update standard operating procedures, system documentation, and knowledge articles.
- Support AI-enabled service-delivery initiatives, including Now Assist and virtual assistant capabilities, through knowledge optimization and identification of potential use cases.
- Monitor knowledge effectiveness, adoption, and recurring support needs and recommend improvements to support operational efficiency and self-service.

5. Systems Standards, Controls & Cross-Functional Collaboration | 10%

- Support the standardization of Talent Acquisition system workflows, documentation, business rules, and operational controls.
- Coordinate with HRIT, HR Operations, TA leadership, and technology partners to support consistent system execution.
- Maintain system process documentation, workflow inventories, enhancement records, and change logs.
- Identify system-related risks, control gaps, and process inconsistencies and escalate issues or recommend corrective actions as appropriate.
- Support technology releases, change readiness, stakeholder communications, and adoption activities.
- Provide operational insights and recommendations to support TA technology planning and continuous-improvement priorities.

Qualifications

**Required**

- Bachelor's degree or equivalent combination of education and relevant experience.
- 3+ years of experience in business operations, systems analysis, reporting and analytics, HR technology, process improvement, or related functions.
- Experience generating reports, analyzing operational data, identifying trends, and developing business-focused recommendations.
- Strong Microsoft Excel skills, including pivot tables, lookups, data manipulation, and trend analysis.
- Experience working with enterprise systems, workflow platforms, or service-management technologies.
- Experience documenting business requirements, workflows, and process improvements.
- Strong analytical, critical-thinking, and problem-solving capabilities.
- Proficiency in Microsoft PowerPoint with the ability to develop clear, compelling presentations for business stakeholders.
- Strong written and verbal communication skills, with the ability to explain data findings and technical concepts to nontechnical audiences.
- Ability to independently manage multiple priorities and assigned deliverables while collaborating effectively with cross-functional stakeholders.

**Preferred**

- Experience with ServiceNow HR Service Delivery (HRSD), including reporting, workflows, knowledge management, or enhancement coordination.
- Experience with HR or Talent Acquisition technologies such as SmartRecruiters, Workday, or similar platforms.
- Experience with Power BI, Tableau, or comparable data-visualization tools.
- Familiarity with automation, AI-enabled workflows, and digital-transformation initiatives.
- Experience supporting user acceptance testing, system implementations, and technology enhancements.
- Experience working in a global enterprise or shared-services environment.
- Understanding of Talent Acquisition operations, recruiting processes, and HR service delivery.

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

Scientist II / Senior Scientist I, tLNP Process Development

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

Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable effective delivery of mRNA. The tLNP chemistry, manufacturing, and control (CMC) team (TCT) is a newly formed group under Biologics CMC, Development Sciences, R&D. TCT focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.

The tLNP Process Development team is seeking a highly motivated, talented, and innovative scientist with expertise in mRNA-LNP process development and an interest in laboratory automation. This team is responsible for the end-to-end manufacturing process from purified mRNA to purified tLNP bulk drug product, including encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via tangential flow filtration (TFF).

The successful candidate will help advance fundamental understanding of tLNP unit operations, such as mRNA encapsulation, bioconjugation, and TFF, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes. The candidate will also apply automation expertise to integrate off-the-shelf and custom-built hardware, software, and data workflows into flexible experimental platforms that increase throughput, reproducibility, and process understanding.

The end goal for tLNP Process Development team is to deliver a robust manufacturing process at commercial scale. This includes science-based, hands-on approaches in the lab to optimize process parameters and understand the impact of process parameters on critical quality attributes. First-principle-based and statistical modeling will be applied where appropriate. Along the pharmaceutical development life cycle, the team will be responsible for successful production of non-GMP pre-clinical safety study supplies and GMP clinical study supplies from a manufacturing plant on site or at third party manufacturers. The team will also lead the tech transfer of commercial processes into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions.

Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development, digital and automation partners, as well as cross-functional partners across Biologics CMC and Synthetic Molecule CMC. The work directly advances cutting-edge mRNA-based therapeutics.

**Responsibilities**

- Independently design, execute and interpret critical experiments to understand unit operations such as mRNA encapsulation, bioconjugation, and tangential flow filtration, and scale up these unit operations to commercial manufacturing batch size.
- Highly autonomous and productive in performing laboratory research or method development, requiring minimal direction from supervisor.
- May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
- Demonstrates high proficiency across a wide range of technologies relevant to tLNP process development.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
- Proactively develop and implement innovative automation solutions (custom and off-the-shelf equipment).
- Apply AI tools for structured data capture, analysis, and predictive modeling.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
- Direct mentorship of others.

Qualifications

- BS, MS, or PhD degree in Chemistry, Material Science, Pharmaceutical Sciences, Bioengineering, Biomedical Engineering, Chemical Engineering, or equivalent.
- **Senior Scientist I**: BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
- **Scientist II**: BS with 7+ years', MS with 5+ years' industry experience.
- Experience with LNP mixing technology in an academic lab, or industry experience with LNP drug product process development. For mRNA encapsulation, experience with systems such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required.
- Possess thorough theoretical and practical understanding of mRNA encapsulation.
- Experience with bioconjugation is required.
- Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions.
- Demonstrated ability to learn, understand, and master new experimental techniques.
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills and strong verbal communication skills.

**Preferred Experience**

- Experience scaling up LNP processes to gram-scale mRNA or above.
- Prior experience with automating existing experimental setups as well as new automation equipment and ecosystems, such as Ignition.

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>)

Novo Nordisk

Hazmat Control Operator I

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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**

Perform all aspects of truck & bulk liquid unloading to support all operations at API-US facility, including Raw Materials & Solvents, Utilities, Purification, Fermentation, Recovery & Warehouse operations. As part of a high performing work team, ensure bulk liquid (including solvents & raw materials) is delivered into API-US systems throughout the tank farm, utility belt & production receiving areas. Additionally, perform duties in SAP/ERP Inventory Control, including material put-away.

**Relationships**

Reports to Manager, RMS & Utilities Operations.

**Essential Functions**

- Loading & unloading product from trucks, tankers & ISO Containers
- Operating pumps & valves; blending & mixing chemicals & products as needed during offloads
- Handling, labelling & storage of hazardous & non-hazardous materials
- Process material handling operations for hazardous materials in drum, pallet & IBC configurations
- Ensure all material movements are performed timely & accurately in SAP/ERP
- Visual & PH inspection on rainwater prior to pumping out containment areas on an as needed basis
- Perform weekly PH probe calibrations utilizing MES/DeltaV
- Replace solvent & boundary filters, based on planned maintenance schedules maintained in SAP
- Partner with warehouse sampling operations in completion of tasks as appropriate
- Daily inspections of the equipment used in offloading chemicals & materials
- Adhering to all plant health, safety & environmental guidelines, policies & procedures
- Keeping work area clean throughout shift
- Maintain up to date training status
- Work in a safe & environmentally responsible manner
- Other accountabilities, as assigned

**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**

- High School diploma/GED, required
- AS degree in related field, or equivalent industrial, military, or vocational training to include a thorough understanding of mechanical, electrical & control systems, desired
- HAZWOPER certification &/or relevant training, desired
- Minimum of two (2) year of truck/bulk liquid unloading or warehousing or equivalent, preferably in a Regulatory Inspected Facility, GMP warehouse or pharmaceutical industry, required
- Basic math skills, including knowledge of metric system, required
- Computer competencies required, including basic Microsoft knowledge: Outlook & Word, preferred
- Knowledge of SAP/ERP to include entry level Warehouse tasks, desired
- Good written & verbal communication skills, required
- Ability to read, write legibly & understand all department documentation, required
- Training or experience demonstrating an understanding of risks inherent to processing, handling & storage of hazardous materials, preferred
- Ability to operate stand-up & sit-down forklifts after applicable training & maintain appropriate licensure, preferred
- Ability to drive non-CDL box truck or similar vehicle for movement of materials on site, required
- Ability to navigate & operate MES & Delta V operating systems, preferred
- Good organizational skills, preferred
- Ability to execute a work plan & adapt to changes in schedule rapidly, preferred

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

Sanofi US

2027 Summer Co-op Process Chemistry, Cambridge, MA

**Job Title:**  *2027 Summer Co-op Process Chemistry*

- **Grade:**  *Co-op*
- **Location:**  *Cambridge, 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 **Summer Co-op** to join our **Process Chemistry team**.

The Process Chemistry team, part of Sanofi's CMC Synthetics organization, is responsible for putting in place the synthetic route, optimization and process design for the commercial manufacturing processes for drug substances undergoing clinical development. Our team strongly believes that innovation is an important driver to reach success. We focus a large part of our activity on developing new synthetic routes, new concepts, and technologies to provide drug substances in a more efficient, more affordable, environmentally benign and intrinsically safe way.

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**

- Contribute to the design and optimization of novel and efficient synthetic pathways for drug substances undergoing clinical development to demonstrate synthetic viability
- Use all imaginable chemistry tools and methods to develop and optimize commercial process for selected drug substance route (photochemistry, biocatalysis, flow chemistry, electrochemistry, on-line analysis/PAT, high-throughput experimentation, structural analysis, computational chemistry, AI/ML and predictive tools, etc.)
- Design, plan and execute experimental plans to optimize reaction, purification and isolation unit operations, guided by technical risk assessments, to deliver safe, efficient, robust and scalable drug substance manufacturing processes that perform reliably at intended scale in batch or continuous format
- Learn to apply green chemistry principles to our R&D programs to develop sustainable manufacturing routes
- Develop/apply analytical techniques for structural characterization and interpretation (NMR and LCMS)
- Perform data analysis such as interpreting experimental results and designing next steps in collaboration with multiple mentors
- Maintain electronic laboratory notebooks according to SOP, provide detailed experimental procedures of laboratory work
- Communicate and interact with other staff/team members in a professional and courteous manner
- Operate in the lab in a safe and efficient manner according to HSE guidelines and adhere to all mandatory company compliance requirements

**About you**

**Basic Qualifications:**

- Currently enrolled in a doctoral degree in Chemistry or a related field.
- 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:**

- Chemistry coursework and lab coursework completed
- Experience in the use of various analytical instruments (e.g., NMR, LCMS) to interpret analytical data and fully characterize novel organic compounds

**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 rate for this position is **$57 USD** hourly. All compensation will be determined commensurate with demonstrated experience.

\#LI-Onsite

\#vhd

null

Massachusetts

Manager, Technical Support (Aseptic Production)

**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**

Lead and manage assigned technical team in a 24/7 operations environment, to include overseeing day-to-day activities, optimizing processes, equipment and systems for efficiency, availability and quality. Manage team members and ensure alignment with the overall strategy of the organization, while implementing strategies and goals set by higher-level managers to contribute to the overall success of the organization.

**Relationships**

Reports to Senior Manager or Manager.

**Essential Functions**

- Manage daily activities of the assigned technical team & ensure practices are standardized across shifts as needed and aligned with the department strategies
- Ensure responsible equipment is designed, available, capable & accessible to meet production & business requirements
- Ensure execution & improvement of technical tasks in alignment with project or site targets based on assigned area of responsibility
- Identify continuous improvement opportunities & implement resulting process improvements to maintain & improve equipment performance & quality
- Schedule & execute plans in coordination with development or manufacturing schedules
- Manage, lead & coach direct reports to ensure a high performing collaborative team environment
- Provide continuous feedback, structure & accountability to improve team performance
- Drive technical discussion & problem solving
- Create, develop, define & implement dynamic key performance indicators for areas of responsibility
- Collaborate with department leadership for oversight of training, development, coaching, performance management, recruitment & employee relations
- Govern behaviour based on the Novo Nordisk Way
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

**Development Of People**

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures and Novo Nordisk Way.

**Qualifications**

- Bachelor’s degree in technical field from an accredited university required
- May consider an Associate’s degree in technical field from an accredited university required with seven (7) years of experience working in Manufacturing, Maintenance, Process or equivalent industry experience
- May consider a High School Diploma or equivalent required with nine (9) years of experience working in Manufacturing, Maintenance, Process or equivalent industry experience
- Minimum of five (5) years of experience working in Manufacturing, Maintenance, Process or equivalent industry experience required
- Minimum of three (3) years of direct supervisory experience required
- May consider demonstrated leadership experience related to technical activities or improvement project initiatives
- Knowledgeable in the following systems: Compressed Air, Steam, Chilled Water, Pharmaceutical Utilities, Filling, Formulation, Sterilization, Water Purification, Assembly & Packaging. Driver for process improvement/design via cLEAN® & Six Sigma methodologies preferred
- Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred
- Ability to relate well to a wide cross section of stakeholders preferred
- Proven expertise, (e.g., project management) in planning/organization & project execution, follow-up & completion preferred

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.

Manufacturing Technician (Nights - Back End)

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.

What we offer you:

- Leading pay and annual performance bonus for all positions
- 36 Paid days off including vacation, sick days & company holidays
- Health Insurance, Dental Insurance, Vision Insurance
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks Paid Parental Leave
- Free access to Novo Nordisk-marketed pharmaceutical products

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

Our team of Manufacturing Technicians is looking for a new colleague to join them as soon as possible! Our department consists of several teams working hard to manufacture our life-saving medicine. This role will be joining our team responsible for the upstream cell culture process of Active Pharmaceutical Ingredients (API) for the medicine we produce. The technicians are continuously working with our teams of engineers, scientists, process associates, facilities support, QA and other stakeholders to improve and simplify our processes. The Manufacturing Technician can expect a dynamic and fast-paced day centered around production activities on our shopfloor. The shopfloor is fully gowned and a clean manufacturing environment (more details in the essential functions).

We are looking for a team player who is curious, energetic, and who likes staying engaged. In this job you will get a chance to develop your production skills via training, experience, and on the job training. And we want our technicians to be encouraged to engage in optimization of our standards & structures on a daily basis. We expect you to be eager to learn and have a can-do attitude when it comes to collaboration, have agility in your day-to-day work tasks, and be able to adapt to changes with a positive mindset.

This role is based onsite at our West Lebanon, NH bioproduction facility with our Back End Nights Manufacturing team, the work schedule for this is as follows:

- Week 1: 7PM-7AM Wednesday - Friday
- Week 2: 7PM-7AM Wednesday - Saturday
- The first 3-4 weeks will be training in our 'bootcamp' for Manufacturing Technicians. Schedule will be Monday-Friday 8AM-430PM, until the transition to the shift schedule

**Relationships**

Reports to: Senior Manager, API Manufacturing

**Essential Functions**

- Product manufacturing and product manufacturing support activities
- Completion of routine documentation associated with the manufacture of product
- Support in-process activities and product development when instructed by supervisor
- Incorporate pre-planned process improvements/cost reduction program into manufacturing
- Perform area equipment and process validations in accordance with validation procedures
- Perform in-process product testing in accordance with standard procedures
- Support manufacturing activities in other departments as instructed by supervisor
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Working in the cleanroom areas may require wearing: hairnet, beard cover, frocks/coveralls, shoe covers, snood, face mask, sterile gloves, and to follow GMP processes at all times. Examples of prohibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelry, cosmetics, nail acrylics, perfume/cologne, and personal cell phone
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.

**Qualifications**

- Education and Certifications:
  - High School diploma or Associates Degree or equivalent with a minimum of three (3) years experience, relevant manufacturing preferred or
  - Bachelors’ Degree in a science discipline with zero (0) years’ experience
- Knowledge, Skills, and Abilities:
  - Knowledge of cGMP operations preferable
  - The ability to understand and execute established written instructions is essential

**Physical Requirements**

0-10% overnight travel required. The ability to climb, balance, stoop, reach, stand and walk. The ability to push, lift, grasp, finger, and feel. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 10 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analysing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, close proximity to moving parts and equipment, and exposure to chemicals; atmospheric conditions including: odours, fumes, and dust.

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.

New Hampshire

Associate Supply Chain Planner - SDF

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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**

Coordinate the logistic flows & ensure that the planning activities are optimal within the production area.

**Relationships**

Reports to Manager.

**Essential Functions**

- Review, challenge & ensure execution of operational planning in collaboration with planning functions
- Proactively identify, analyse & respond to potential issues affecting raw material planning, production planning or supply chain overall
- Collaborate closely with suppliers & internal stakeholders to optimize schedules & production plans
- Support the planned shipment of finished products to external customers according to order dates or inventory policies
- Ensure material availability to production through purchase planning, goods receipt, sampling and release flows
- Monitor, analyse and report on Supply Chain KPI’s
- Implement LEAN & flow in the plant, proactively, show a LEAN mindset
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role).

**Qualifications**

- Bachelor’s degree in Supply Chain Management or related field from an accredited university is required
- One (1) year of experience in Supply Chain Management, production planning, material planning, supplier management or related field preferred
- Excellent verbal & written communication skills; good presentation skills required
- Computer skills including experience with Microsoft Excel & electronic material management systems preferred
- Familiarity with SAP (APO & ECC) preferred
- Proven process improvement & problem-solving skills preferred
- Experience in LEAN manufacturing 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.

Supply Chain Engineer

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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**

This strategic role combines aspects of both supply chain & process improvement. It is responsible for optimizing the NNPILP Supply Chain through data analysis, problem solving and execution of changes including technical improvement projects focused in Planning, Warehousing, Procurement & Shipping. This role will also serve as a technical expert and lead for Supply Chain for site various projects.

**Relationships**

Reports to Manager, Supply Chain/Manager, Warehouse/Sr PM-Site Capacity.

**Essential Functions**

- Data analysis, problem solving and execution of changes in Planning, Warehousing, Procurement & Shipping
- Execute transformation program strategies and projects in collaboration with Supply Chain management
- Define key activities or improvement projects and propose the associated deadlines. Including the pre-requisites and interfaces with other projects or programs
- Secure decision making throughout the program to assure deadlines are met. Adjust and update the programs according to the progress made on the established governance of the program to ensure: Sharing, monitoring and control of the program
- Propose risk mitigation actions and communicate and at different levels of the organization
- Monitoring of the necessary resources needed for execution
- Leads continuous improvement projects, drive SPS to closure and identify any anomalies that have arisen and identify corrective actions
- Carry out necessary investigations to optimize/ make operations more reliable
- Provide engineering design support for Supply Chain facility/equipment changes & additions
- Serve as the technical expert in Warehouse automation
- Overseas operational training needs and performs training to ensure standards are met
- Responsible for investigation & solution of quality problems in department such as: unscheduled events, deviations, etc
- Other accountabilities, as assigned

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

**Qualifications**

- Bachelor's Degree in Engineering or Supply Chain required
- Minimum 10 years of manufacturing, supply chain or logistics experience, preferably in a pharmaceutical environment preferred
- Project Management experience a plus
- Proven experience using Lean/Six Sigma methodologies & achieving sustainable process improvements required
- Demonstrated experience in practical problem solving & process improvement methods required
- Minimum of five (5) years of experience in SAP or equivalent required
- Experience with robotics and automation a plus
- Knowledge of US, EU regulations & guidelines & application of GMP’s a plus
- Ability to communicate technical information clearly in writing & presentations preferred
- Experience planning, organizing, managing execution, checking results & revising work plans preferred
- Strong communication skills across multiple organizational levels preferred

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.

Sr. Manager, Clinical Process Engineer

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

**Purpose statement**

Lead the design, optimization, and sustainment of clinical business processes across multiple functional domains to enable operational excellence, regulatory compliance, and scalable innovation within Clinical Development Operations. The Senior Manager, Clinical Process Engineer operates with significant independence, driving cross-functional alignment and translating complex, ambiguous business challenges into fit-for-purpose process solutions. This role shapes how process engineering work gets done across the function and builds the credibility and relationships needed to influence without authority.

**Major responsibilities**

1. Lead end-to-end process design and optimization across multiple clinical domains or workstreams simultaneously, managing ambiguity and competing priorities with minimal direction.
2. Serve as a primary process engineering resource for BPOs and functional leaders, advising on process strategy, design decisions, and tradeoffs.
3. Develop and govern process maps, work instructions, SOP-aligned content, and documentation standards across assigned domains; ensure consistency and scalability across teams.
4. Lead comprehensive current-state assessments and multi-variable process analyses to surface systemic issues, prioritize improvement opportunities, and recommend enterprise-aligned solutions.
5. Design and lead complex process design workshops across multi-stakeholder environments, including navigating competing interests, driving to decisions, and managing escalations appropriately.
6. Ensure process designs are built for inspection readiness, quality by design, and long-term operational sustainability; proactively identify and mitigate compliance risk embedded in process.
7. Lead process-to-system translation efforts, partnering with technology teams, business system owners, and program leadership on requirements, UAT, and readiness.
8. Define and implement process performance frameworks; recommend KPIs and instrumentation strategies; present findings and improvement recommendations to functional leadership.
9. Maintain and continuously improve controlled documentation practices across a domain; contribute to governance standards and documentation policy development.
10. May manage 0–4 direct reports; responsible for performance management, development planning, and building a high-performing, accountable team culture.

Qualifications

- Bachelor's degree in engineering, life sciences, business, or a related field required; advanced degree preferred.
- Lean Six Sigma certification required; Green Belt or Black Belt preferred.
- Minimum **7 years** of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).
- Strong knowledge of clinical development operations and associated regulatory, inspection, and quality expectations.
- Expert proficiency in process mapping, documentation methods, and tools; demonstrated ability to develop scalable process artifacts and standards across teams.
- Proven ability to lead complex, multi-stakeholder workshops and drive cross-functional alignment to decisions under ambiguity.
- Advanced analytical skills (e.g., root cause analysis, multi-variable risk assessment, process performance analysis); ability to translate data into strategic recommendations.
- Demonstrated experience leading process-to-system initiatives, including requirements definition, UAT strategy, and system readiness.
- Executive-level written and verbal communication skills; able to present complex process topics to senior stakeholders with clarity and confidence.
- Track record of managing multiple high-priority workstreams in a matrixed, global environment with high accountability and independent judgment.

**Key stakeholders**

- BPOs, Process Experts, and functional leaders.
- Clinical Development Operations senior leadership and operational teams.
- Process Excellence / process architecture and governance leads.
- Quality, compliance, and inspection readiness leadership.
- Change engagement, learning, and training partners.
- Technology and business system leaders.
- Cross-functional governance forums and program leadership teams.

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 long-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>)

Associate Director, Clinical Process Engineer

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

**Purpose statement**

Own and evolve the clinical process engineering capability within Clinical Development Operations, establishing the methodology, standards, and governance infrastructure that enable scalable, inspection-ready, and operationally excellent processes across the enterprise. The Associate Director, Clinical Process Engineer is the functional authority on process design and engineering practice, operating at the intersection of strategy, compliance, and execution. This role shapes how the discipline works, not just what it delivers, and is accountable for building the infrastructure and talent that sustains the capability long-term. Operates within a multilayered leadership structure and is expected to bring enterprise-level judgment and strong upward credibility.

**Major responsibilities**

1. Define and own the clinical process engineering methodology, standards, and toolset used across Clinical Development Operations; drive adoption and continuous evolution of the practice.
2. Serve as the enterprise subject matter authority on clinical process design, advising senior and executive leadership on process strategy, capability investments, and cross-functional process architecture.
3. Oversee the design and governance of end-to-end clinical processes across the enterprise; ensure coherence, scalability, and inspection readiness across domains and programs.
4. Lead enterprise-level current-state assessments and strategic process analyses; translate findings into capability recommendations and program-level improvement roadmaps for executive audiences.
5. Design and lead high-stakes, enterprise-wide process workshops and governance forums; manage executive-level stakeholder dynamics, resolve competing priorities, and drive strategic alignment.
6. Establish and own the process compliance, inspection readiness, and quality-by-design frameworks for the function; proactively manage risk and partner with quality and regulatory leadership on emerging expectations.
7. Lead and govern complex, cross-enterprise process-to-system programs; accountable for the quality and integrity of process design inputs feeding technology platforms and transformation initiatives.
8. Own the process performance measurement framework for the function; define enterprise KPIs, oversee reporting infrastructure, and present insights to senior leadership and governance bodies.
9. Set and govern documentation standards, decision record practices, and process governance infrastructure across Clinical Development Operations; responsible for audit readiness at a function-wide level.
10. May manage 0–5 direct reports; responsible for team leadership, talent strategy, performance management, and building a differentiated, high-impact process engineering capability.

Qualifications

- Bachelor's degree in engineering, life sciences, business, or a related field required; advanced degree strongly preferred.
- Lean Six Sigma Black Belt or equivalent preferred; Green Belt required.
- Minimum **8 years** of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar), with progressively increasing scope and complexity.
- Deep expertise in clinical development operations and regulatory, inspection, and quality frameworks, including the ability to advise senior leadership on emerging compliance expectations.
- Expert proficiency in process mapping, methodology development, and governance design; demonstrated experience building and scaling process engineering capabilities within a large, regulated organization.
- Proven ability to lead enterprise-level, multi-stakeholder programs and governance forums with executive presence and strong facilitation skills.
- Strategic analytical skills; ability to synthesize complex, multi-variable environments into executive-ready insights and capability recommendations.
- Demonstrated experience leading large-scale process-to-system transformation programs, including stakeholder alignment, risk management, and program governance.
- Exceptional written and verbal communication skills; experienced presenter to senior and executive leadership.
- Proven track record of leading high-performing teams, building capability, and operating with enterprise-level judgment in a complex, matrixed, global organization.

**Key stakeholders**

- BPOs, Process Experts, and functional senior leadership.
- Clinical Development Operations executive leadership and governance bodies.
- Process Excellence leadership, process architects, and enterprise governance leads.
- Quality, compliance, regulatory, and inspection readiness leadership.
- Change, learning, and transformation leadership.
- Technology and digital platform leadership.
- Cross-functional program leadership, governance forums, and enterprise initiative sponsors.

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 long-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>)

Clinical Operations Manager

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 people. Strengthen site partnerships. Help accelerate clinical research.**

AbbVie is looking for a **Clinical Operations Manager** to join our Sydney team on a **12-month max-term contract**.

You’ll lead and develop a team of clinical research professionals while helping drive the delivery of priority clinical programs across Australia. Working closely with investigators, research sites and cross-functional stakeholders, you’ll remove barriers to execution, strengthen capability and help ensure studies are delivered with quality, pace and impact.

With exposure across people leadership, study delivery, resource planning, site engagement, feasibility and operational improvement, this is an opportunity to make a visible contribution to both our clinical research team and AbbVie’s pipeline.

**KEY DUTIES AND RESPONSIBILITIES**

- Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
- Provide leadership and oversight to the clinical research team including, but not limited to:
  - performs accompanied site visits (on-site and off-site)
  - accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
  - conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel and broader team
  - addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics.
- Utilizes AbbVie systems and tools to proactively address performance and mitigate risks and issues. Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities of their assigned studies.
- Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies. Prepare and follow up on site and country audits, CAPA preparation and implementation.
- Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions.
- Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable
- Leads and supports the team to understand the business strategy and vision. Supports team to connect strategy to execution and promote collaboration with stakeholders to effectively deliver pipeline.
- Drives and implements change through effective communication and management
- Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
- Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
- May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Country Clinical Operations Manager (CCOM). Proactively identifies opportunities at local/global levels and proposes solutions to create efficiencies and streamline/improve processes.
- Oversight and delivery of country and site feasibility activities in alignment with local and global strategy and expanding AbbVie’s footprint within the country.
- May be assigned on or multiple TA responsibilities within country/ies. Support training and monitoring for the team. Develop and implement strategies to support pipeline execution. Collaborate with local and global cross functional partners including Medical Affairs or commercial brand teams as appropriate.
- Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical research.
- Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
- Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.

Qualifications

- Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy)
- Minimum 5 years plus monitoring experience at least 1 year of direct line management experience preferred.
- Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
- Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
- Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships.
- Demonstrated proactive and positive team player.
- Exhibits strong planning and organisational skills.
- Experience across multiple therapeutic areas and study phases
- Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
- Drives innovation and continuous process improvement.
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
- Deals comfortably with risk and ambiguity, changing courses when needed.
- Ability to make timely, high-quality decisions based on available data and information.
- Ability to work independently and take initiative/ownership.
- Ability to adapt and move quickly

**Flexibility and Availability**: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing CareersANZ@abbvie.com or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

**WAYS WE WORK**

- All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
- Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
- Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
- Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
- Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

**CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT**

- AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
- AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
- All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
- Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
- AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

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

Technician, Pilot Plant III

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

Responsibilities:

- Learn and follow department policies, procedures, and guidelines. Complete documentation and supporting data per current good manufacturing procedures policies, procedures, and guidelines.
- Maintain a safe and clean work environment. Note quality issues and address with appropriate people.
- Utilize systematic work habits that show effective organizational skills.
- Ability to foresee process requirements and prepare for them.
- Review procedures and batch records, and make suggestions for improvements. During pre runs, post runs, and when reviewing direction sets identify issues (safety and process) and help to correct them.
- Consistently give an accurate and complete material and equipment status report when handing off manufacturing process Communicate with warehouse to ensure timely and proper staging for process.
- Looks for ways to improve efficiencies and reduce costs. Understands changes in work tasks, situations, and environment.
- Actively seeks new information about work situations and adapts to change in work schedule and environment with little or no disruption.
- Puts new knowledge, understanding, or skills to practical use on the job. Effective in demonstrating new skill and knowledge and does not persist in ineffective behavior.

Qualifications

- High school diploma or GED equivalent required; Bachelor’s or Associate’s Degree in a scientific related field is desirable.
- At least 2 years manufacturing experience in a chemical, pharmaceutical, or similar environment as an operator or Technician is required.
- Knowledge and use of various tools, machines, instruments, and safety devices utilized in chemical or pharmaceutical operations is desired.
- Basic technical or mechanical background and knowledge.
- Must have ability to read, understand, and follow verbal and written operating instructions and the processes and flows described on equipment and computer monitors.
- Write at a level sufficient enough to explain deviations or mistakes in the process. Add, subtract, divide, multiply, use decimals and fractions, recognize and measure proportions, and do basic algebraic math at an intermediate level of competency.
- Consistently execute tasks successfully for which training is completed

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>)

Director, Program Management

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 Director, Program Management will be responsible for the overall program implementation and oversight for assigned manufacturing and capital programs within the Engineering organization. The individual will be required to lead a cross-functional team to ensure program deliverables are achieved with adherence to approved budgets. The individual must have the ability to work independently, and also as an effective and engaged team leader.

**Responsibilities:**

- Lead and direct multiple cross-functional teams for the implementation of complex programs, managing strategy, execution and budget.
- Establish program strategy and timelines, defining technical and regulatory requirements to support regulatory approvals.
- Evaluate contingency plans and risk management strategies.
- Ensure effective communication within team and to Senior Leader stakeholders.
- Lead team discussions to resolve issues and ensure team alignment throughout program execution.
- Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules per financial schedule.
- Communicate program requirements, priorities and decisions, regularly and effectively.
- Guide cross-functional team in resolving conflicts and indecision's. Escalate when necessary.

Qualifications

- Bachelor in Science or Engineering; MBA preferred.
- Strong knowledge of GMP Manufacturing, Supply Chain, CMC technical development and pharmaceutical regulations is required.
- Demonstrated strong planning and project management skills while managing large, complex programs in the pharmaceutical industry.
- PMP certification a plus.
- 10+ years of industry experience, 5 or more years program management experience.
- Strong strategic thinking and leadership skills.
- Strong communication, organization, analytical, presentation, and people skills.
- Demonstrated experience in a global and multi-cultural environment.
- Proven ability to resolve conflict across cross-functional teams and technical experts.
- Ability to understand technical aspects of complex systems and guide cross-functional and detailed technical discussions during critical problem solving exercises

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 long-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>)

GenScript

Equipment Engineer

**About GenScript**

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

**Job Title:** Equipment Engineer

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

**Reports to:** Manager II, Engineering

**Compensation:** The estimated salary range is $65,000 - $75,000, dependent upon experience level.

**Job Overview:**

The Equipment Engineer reports to the Manager II, Engineering and supports laboratory and production equipment at our Piscataway, NJ facilities. This hands-on role maintains and repairs assigned equipment, improves reliability, and keeps complete records of equipment work.

The engineer performs appropriate preventive maintenance, troubleshooting, repairs, and calibration activities internally. OEM and third-party providers are used when specialist tools, qualifications, warranty terms, or capacity require outside service.

**Job Responsibilities:**

**Hands-On Maintenance and Repair:**

- Perform scheduled preventive maintenance and appropriate calibration activities on assigned laboratory and production equipment, following approved procedures and documenting results.
- Diagnose equipment failures, perform hands-on repairs within training and authorization, verify performance, and coordinate return to service with equipment users and Quality as applicable.
- Support a range of instruments, which may include liquid handlers, automated systems, HPLC systems, centrifuges, thermal cyclers, analyzers, and general laboratory equipment.

**Vendor and Service Management:**

- Determine when work should be outsourced to an OEM or qualified service provider and define the service needed.
- Schedule and coordinate vendor visits for repairs, preventive maintenance, and calibration; prepare equipment and access, oversee work on site, and communicate timing to users.
- Review vendor service reports and calibration certificates, confirm the work is complete, and follow up on unresolved issues before closing the work order.

**Asset and Work Order Management:**

- Create and maintain CMMS work orders for failures, repairs, preventive maintenance, and calibration. Record symptoms, troubleshooting, work performed, parts used, results, attachments, and equipment status.
- Maintain accurate asset histories, maintenance schedules, calibration due dates, and equipment inventory records; identify critical spares and support inventory planning.
- Develop and improve clear technical procedures and maintenance instructions for assigned equipment.

**Reliability, Quality, and Compliance:**

- Review work order history for repeat failures, downtime, and recurring costs; investigate causes and recommend improvements to maintenance plans, spares, or vendor support.
- Perform and document equipment work in accordance with applicable site procedures and Quality requirements.
- Support equipment-related deviations, root cause investigations, and corrective actions in collaboration with Quality and equipment users.

**Communication and Collaboration:**

- Communicate equipment status, risks, and expected recovery times to laboratory and production users, management, and the Equipment team.
- Coordinate work with users to minimize disruption and share troubleshooting knowledge with other team members

**Qualifications:**

- Bachelor's degree in Engineering or a related technical or scientific field, or equivalent relevant technical experience.
- Three or more years of relevant equipment engineering, maintenance, field service, or calibration experience is preferred.
- Hands-on experience maintaining and repairing laboratory equipment is preferred; experience with laboratory equipment troubleshooting and calibration is also preferred.
- Ability to use a computerized maintenance management system (CMMS) or similar work order system to document work and track scheduled maintenance.
- Experience coordinating OEM or third-party service providers and reviewing completed service work is preferred.
- Familiarity with applicable GMP, ISO, or other regulated quality practices is helpful; ability to follow site procedures and maintain accurate records is required.
- Strong problem-solving, organization, and communication skills, with the ability to prioritize equipment needs and work effectively with laboratory, production, and Quality teams.

\#LI-EB1

\#GS

**Benefits:**

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

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

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

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

New Jersey

BSL III HVAC Technician - 2nd Shift

**Job Title:** BSL III HVAC Technician - 2nd Shift

**Location:** Swiftwater, PA

**Shift:**  2nd shift. Tuesday-Saturday (3pm-11:30pm) subject to work Holiday and Weekends depending on business needs with mandatory overtime

**About the Job**

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Maintenance Technician is responsible for supporting the design, installation, maintenance, troubleshooting, and repair of all site wide equipment in order to maintain a quality Class A environment in GMP, GLP and non GMP facilities at the Swiftwater site.

This position reports to and supports the area team Maintenance Manager or Deputy Director who is ultimately responsible for the efficient, effective, and reliable operation of all equipment in their area. The Maintenance Technician will have interactions with all levels of the organization including HSE, M&S (manufacturing & Supply), Engineering, External Contractors, R&D, Msat, and various other support groups.

The Maintenance Technician is a member of a maintenance team that supports GMP, GLP and/or non GMP, areas at the Swiftwater site. The equipment and systems include both GMP, GLP and non GMP areas. The 7/24 GMP production environment requires maintenance under regulated conditions. The work performed by the Maintenance Technician and documentation of this work has a direct impact on the manufacturing operations and quality results of the site.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

**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:**

- The ability to multitask, troubleshoot HVAC, electrical and mechanical systems, evaluate and repair site wide equipment is critical to the success of this role and the maintenance department.
- This position requires the HVAC technician to work on intricate and site-specific equipment and systems.
- Technicians to work up to 25% overtime with short notice and working various shifts depending on business needs and production cycles.
- The Maintenance Technician interfaces closely with the customer to provide reliable, safe, and efficient equipment operation and uptime.
- Timely execution of preventive/corrective maintenance
- HSE considerations for maintenance (permits, PTW, LOTO)
- WO accuracy and completeness
- Continuous improvement for maintenance operations

**Preventive maintenance and repairs on industrial and process equipment including but not limited to the following:**

- Refrigerated cold box and freezers
- Autoclaves
- Process control devices
- Pump repairs, rebuilds, replacement
- Motor replacement and alignment
- Schematics and the ability to read blueprints
- Electricity including DC controls, single phase and 3 phase up to 480V
- Refrigerators, freezers, and incubators
- Process chillers and temperature control units
- Water For Injection (WFI) Clean Steam, RO/DI, Purified water
- Replacement of valves and piping system repairs
- Basic computer skills in MS Office and SAP
- Air Handling Unit Operations
- Tensioning of belts and alignment
- Bearing replacement
- Knowledge of VFDs, VAVs,
- Knowledge of steam principals
- JCI Metasys Systems

**About You**

**Basic Qualifications:**

- Bachelors or Associate degree with 2+ years of experience in equipment maintenance
- High School Diploma or GED with 5+ years of experience in equipment maintenance
- In-depth equipment knowledge and strong troubleshooting skills
- Understanding of precision maintenance concepts

**Preferred Qualifications:**

- Strong Electrical knowledge and experience with troubleshooting electromechanical systems
- Relevant training and certifications in maintenance or related fields
- Working knowledge of Computerized Maintenance Management Systems (CMMS) helpful

**Physical Requirements & Special Working Conditions**

- Lifting: Specify : \> 20 lbs.
- Temperature Extremes
- Uncomfortable Protective Clothing
- Excessive Noise
- Unpleasant Fumes
- Dust or Dirt
- Adverse Weather Condition
- High Voltage \> 50 volts
- Steam, Hot Water, Compressed Air, Waste Water

**Employment Conditions:**

- Must be in the Medical Surveillance Program
- Support 24/7 coverage of BSLIII facility
- Participate in FBI Clearances
- Be able to pass and maintain N95 and Full-Face Respirators Certification

**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

\#vhd

\#LI-Onsite

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

Tris Pharma

Metrologist II

Tris Pharma, Inc. ([www.trispharma.com](<http://www.trispharma.com/>)) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have \>150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

**Our Metrology Department, located in our Monmouth Junction, NJ headquarters has an immediate need for a Metrologist II.**

**SUMMARY**

The Metrologist II supports Analytical laboratories by performing routine calibration and instrument performance verification, maintenance and repairs on instrumentation including, but not limited to: High Pressure Liquid Chromatography/Ultra Performance Liquid Chromatography (HPLC/UPLC), ultra-violet visible spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc. following analytical methods, United States Pharmacopeia (USP)/National Formulary (NF) Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies.

Collaborating closely with, and under the direct supervision of laboratory management, the incumbent carries out laboratory work to support laboratory activities and performs special projects as assigned. She/he also writes and assists investigation related to instrument calibration failures or other instrument related issues.

**ESSENTIAL FUNCTIONS**

**Primary duties/responsibilities**

· Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws

· Performs routine calibration and instrument performance verification, maintenance, and repairs on more complicated instrumentation such as HPLC/UPLC, GC, H-class, UV-Vis, FTIR, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.; Performs routine daily calibration/verification checks for balances, pH meters, etc.

· Processes and reports calibration results using instrument specific data processing software; Documents all activities in legible manner following established formats and good documentation procedures

· Initiates, writes and assists investigation related to instrument calibration failures or other instrument related issues

· Contacts and obtains technical information from vendors or service providers

· Analyzes samples to evaluate instrumentation performance and troubleshoot instrument malfunction and/or breakdown, etc.

· Trains and mentors lower level Metrologists and assists them during routine metrology

· Safely and properly dispose of chemical waste, as needed

· Complies with all company policies and procedures, including safety rules and regulations

· Adheres to cGMPs and current Good Documentation Practices (cGDPs)

Requirements

**KNOWLEDGE/SKILLS/ABILITIES REQUIRED**

**_Minimum education and years of relevant work experience_**

Bachelors in Chemistry, Engineering or related scientific field and minimum 3 years lab experience in a GMP related industry or minimum 4 years related experience handling analytical equipment in pharmaceutical or biotechnology industry working in Metrology, Method Validation (MV), Quality Control (QC) or related laboratories.

**Special knowledge or skills needed and/or licenses or certificates required:**

· Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations, and guidelines.

· Hands on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical instrumentation (i.e., HPLC/UPLC, GC, Dissolution Apparatus and Autosamplers, UV-Vis, Density Meter, Balances, Ovens, Viscometers, Melting Point apparatus, Refractometer, Polarimeter, Media Dispenser Ezfill, etc.)

· Proficiency with Microsoft Office

· Verbal and written communication and skills

· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

· Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

· Planning, organization and time management skills including the ability to support and prioritize multiple projects

· Fluent in English (verbal and written)

· Ability to identify and distinguish colors

· Ability and willingness to work additional hours required by business needs

**Special knowledge or skills needed and/or licenses or certificates preferred:**

· Experience performing or assisting in laboratory or metrology investigations

· Experience working in laboratories supporting testing of multiple dosage forms of products (i.e., solid dosage forms, liquid dosage forms, suspensions, etc.)

· Proficiency with Empower and/or other laboratory software

**Travel requirements:**

0%

**Physical requirements:**

· Laboratory based position

· Ability to lift up to 30 lbs

· Ability to use Personal Protective Equipment (PPE)

· Ability to stand for extended periods of time

**Anticipated salary range:**  Metrologist II: $75,000 to $95,000 annually. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

**Additional benefits:**  In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-\_

Amgen

Senior Engineer

**Join Amgens Mission of Serving Patients**

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

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

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

**Sr Engineer**

**What you will do**

Lets do this. Lets change the world. In this role the Line Owner/System Owner must work under general supervision, owns all the technical aspects in a manufacturing line. The processes were the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define designs requirement to the service providers to fulfill area technical and equipment needs.

**Specific responsibilities include but are not limited to:**

- The original work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgens 24-hour operations. These shift structures can be a great opportunity to better support individual work / life priorities.
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- Initiate and complete routine technical tasks.
- Operations Engineering:
- Function as a technical specialist to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
- Design Engineering:
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects and engineering firms on development of standard design documents.
- Obtain and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.

**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**

OR

Masters degree and 2 years of Packaging manufacturing or Automation controls experience

**Or**

Bachelors degree and 4 years of Packaging manufacturing or Automation controls experience

**Or**

Associates degree and 8 years of Packaging manufacturing or Automation controls experience

**Or**

High school diploma / GED and 10 years of Packaging manufacturing or Automation controls experience

**Preferred qualifications**

- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes for Packaging areas
- Familiarity with serialization process and networking
- Familiarity with documentation in a highly regulated environment
- Ability to operate specialized equipment, tools and computers as appropriate.
- Ability to interpret and apply GMPs.
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
- Comprehensive understanding protocol execution requirements.
- Problem solving and applied engineering.
- Basic technical presentations
- Personal Organization
- Protocol and script testing Writing
- Dealing with and handling change
- Packaging Equipment Technical knowledge
- Analytical Problem Solving
- Computer Literacy

**What you can expect of us**

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

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

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

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

**Apply now 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.

Ohio

Eli Lilly and Company

Supervisor - Aseptic Filling (Day Shift)

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Position Description:**

**Company Overview**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world and embody our company values of **Integrity**, **Excellence**, and **Respect for People**

**Position Overview**

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company’s capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.

If you ever wanted to have a direct impact building a team’s culture and in how the team operates, now is the perfect opportunity!

During the project phase, the Operations Supervisor (Filling) will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities.

Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR departments. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.

As a site leader and expert at our growing site, you’ll have significant opportunities for growth into future leadership and technical roles.

**Key Objectives / Deliverables:**

**Integrity**

- Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
- Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
- Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.

**Excellence**

- Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts.
- Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.
- Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.
- Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.
- Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.
- Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.

**Respect for People**

- Support the site in building a diverse, empowered, and capable team.
- Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.
- Responsible for the coaching, development, and performance evaluation of operators.
- Communicate cross functionally with support team if there are quality, equipment, operational concerns.

**Basic Qualifications/Requirements:**

**Education, Experience and Skills**

- High School Diploma or equivalent
- Current supervisory experience in a GMP environment
- Basic computer skills (desktop software, MS Office) are required.
- Experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).
- Excellent interpersonal, written, and oral communication skills
- Strong organizational skills and ability to handle and prioritize multiple requests.
- Strong technical aptitude and ability to train and mentor others.

**Time Commitments and Work Authorization**

- Ability to work overtime as required
- Willingness to work a 12-hour day shift (6am to 6pm on 2-2-3 schedule)
- Ability to wear safety equipment (glasses, shoes, gloves, etc.)
- Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Preferred attributes but not required:**

**Experience with, completion of, or understanding of:**

- 10+ years in manufacturing/operations with 4+ years in supervisory role
- cGMP standards and FDA (or other industry) guidelines for production
- STEM degree or certification
- Aseptic filling, single use assemblies, isolator technology.
- Automated, semi-automated, and/or manual inspection.
- Highly automated equipment (inspection, packaging, filling, assembly, etc.)
- Manufacturing Execution Systems and SAP or other electronic business systems
- Continuous improvement methodologies and mindset – lean, six sigma, etc.
- Root cause analysis and implementing corrective actions
- Ability to organize and motivate teams
- Facility, Equipment, Systems, Start-up

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$35.33 - $57.12

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Legend Biotech

Investigations Supervisor

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an **Investigations Supervisor** as part of the **Manufacturing & Supply** team based in **Raritan, NJ.**

**Role Overview**

The CAR -T Investigation Supervisor will work with the investigation team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.

**Key Responsibilities**

- Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
- Assign investigations to team members and track them to completion
- Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
- Perform investigations and train new investigators.
- Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
- Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
- Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Partner with all stakeholders to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Maintains various databases of production information.
- Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
- Review and approve SOP and Batch record revisions.

Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals

**Requirements**

- BS/BA required in technical discipline: Engineering, science or similar field.
- A minimum of six (6) years of professional relevant business experience.
- Demonstrated experience in completing complex investigations independently.
- Knowledge and solid understanding of cGMP regulations and FDA/EU guidance
- Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.
- Excellent written and oral communication skills
- Ability to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community.
- Experience with internal and external regulatory audits.
- Ability to utilize various standard programs for data entry and word processing.
- Language(s): English

\#Li-BZ1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$110,706 - $145,303 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Filter Validation Execution Lead

**Job Title**:Filter Validation Execution Lead

- **Location:** Swiftwater, PA

**About the Job**

Sanofi delivers 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSATfulfillsan important function by providing day-to-day manufacturing support, focusing on technical and process aspects, effective life cycle management, process robustness enhancement, and yield improvements to optimize performance.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster

**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 lives.

**Main Responsibilities**

- The Filter Validation Execution Lead is responsible for designing and executing development and validation studies for sterilizing-grade filters, virus filtration filters, bioburden reduction filters, and vent filters.

- Responsible for managing the execution of studies aligned with the project schedule and communicating with stakeholders (external labs, the project team, and MSAT Management).

- Partner with MSAT product experts to assess new filtration needs, and support screening studies to define and optimize filter selection.

- Responsible for drafting, reviewing, and approving documents such as filter validation protocols, reports, Validation Project Plans (VPP), technical assessments, and deviations.

- Responsible for driving Corrective and Preventive Actions (CAPAs) and Change Controls related to filter development and validation.

- Responsible for coaching and mentoring junior personnel and contractors on technical knowledge regarding filter validation principles and practices.

- Support the Subject Matter Expert (SME) to optimize the filter validation program and ensure the program remains compliant with changes to guidelines related to filter validation.

- Support all internal and external audits and regulatory inspections related to filter validation.

- Participate in the filtration validation expertise network within Sanofi and externally.

- Lead and/or participate in any filter validation investigations and troubleshooting activities.

- Build and maintain strong relationships with partners, cross-functional experts, and customers to achieve technical objectives.

**About You**

**Basic Qualifications**

**Experience:**

- Demonstrated experience managing execution deliverables to achieve strategic objectives.

- Preferred: 2+ years of experience in protocol writing, data pack assembly and report writing for filter validation.

- Contributing to collaboration and harmonization initiatives in support of a vision for future production processes and technologies.

- Demonstrated ability to work with a high level of autonomy with limited guidance.

- Experience in cleaning, shipping, and Extractables and Leachable (E&L) validation is a plus.

**Soft skills:**

- Behaves according to company values and competencies.

- Encourages and ensures proactive and strong collaboration internally and across functions; forward thinking with an attitude of optimization, efficiency, continuous improvement, and smooth transitions between functions.

- Use experience and knowledge to propose continuous improvements that deliver efficiency gains.

- Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions, and actions for resolution.

- Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.

**Technical skills:**

- Knowledge of regulatory expectations around filter design, qualification, and testing (e.g., FDA, EMA, PDA Technical Reports).

- 2+ years of hands-on experience for qualification and testing of filters used in vaccine manufacturing.

- Strong communication skills with the ability to discuss technical topics effectively through both oral and written communication.

**Educations:**

- Bachelors degree in basic sciences, mathematics, engineering, or pharmacy with 2+ years work experience in Filter Validation field.

- Candidates should possess educational and professional experience, commensurate with the position.

**Terms of employment:**

- The hired candidate will execute role as an individual contributor.

- The hired candidate will work during normal business hours (8am 5pm Monday Friday), but flexibility for occasional work outside of these hours is necessary.

- Preferred Start Date: September 2026

**Why choose us?**

- 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 andwellness programs and at least 14 weeksgender-neutral parental leave.

- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale

- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. 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

\#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>)