Manufacturing & Production

Sanofi US

Production Technician

**Job Title:**  Production Technician

**Location:** Pearl River, NY

**About the Job**

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.

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.

Primary responsibility of the incumbent will be operation of general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the downstream processing (Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. In addition, perform aseptic sampling (Environmental monitoring sampling, WFI, PUW and Clean Steam Sampling).

Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and sanitization of all downstream processing equipment such as stainless-steel vessels including transfer lines, ancillary equipment (tube welders, tube sealers, peristaltic pumps), use of water-for-injection (WFI) point of use taps, etc. Activities will include executing techniques such as large-scale centrifugation, depth filtration, chromatography column purification and packing, tangential flow filtration, and clean-in-place and steam-in-place of process equipment.

Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and turbidity meters). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in downstream and buffer preparation areas. Business needs may also require database entry, cross training and operations in flex areas.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

**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:**

- In depth understanding of techniques and processes being executed on routine basis.
- Responsible for all aspects of downstream and buffer preparation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
- Responsible for the operation and maintenance of ancillary equipment such as pH / conductivity meters, turbidity meters, tube welder, tube sealer, peristaltic pumps, etc.
- Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
- Technician should have the ability to manage and analyze manufacturing data.
- Ability to take initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
- Ensure good documentation practices (GDP) in execution and reviews of production records.
- Responsible for all required cGMP training including additional training assigned by their manager.
- Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
- Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
- Work a flexible work schedule, weekends and holidays as required, and as needed by department.
- Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
- Other duties as they are required.

**About You**

**Requisite Educations/Skills:**

- High School Diploma with at least 1 year of work experience
- Bachelors Degree with no prior experience
- Training within a cGMP manufacturing environment is preferred
- General knowledge of cGMP, GDP, SOPs
- English fluent, both written and spoken
- Good communication and social skills
- Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job and include the ability to stand over intervals of several hours at a time, ability to bend, squat, and reach, and ability to lift, push, or pull various amounts of weight up to approximately 50 lbs. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials.

Based on production schedules, different start time scenarios may occur, requiring a flexible work schedule for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands.

**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 weeks gender-neutral parental leave.

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

\#GD-SP

\#LI-SP

\#LI-Onsite

\#vhd

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

New York

Novo Nordisk

Senior Specialist Logistics

**About the Department**

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference.

**The Position**

This role is responsible for overseeing and executing domestic logistics operations for the Boulder site, serving as the primary point of contact for all shipment-related activities. The position manages the end-to-end movement of research materials, raw materials, drug substances, and drug products, ensuring timely delivery, compliance with trade regulations, and effective communication with internal and external stakeholders. Key responsibilities include coordinating shipments, monitoring critical milestones, completing shipping documentation, and supporting import/export compliance activities as needed. The role also drives operational excellence through continuous improvement of shipping processes, shipment tracking systems, and outsourced inventory management. It partners with contract manufacturers, warehouses, quality assurance, and other stakeholders to optimize inventory, investigate logistics-related deviations, implement corrective and preventive actions (CAPAs), and ensure product integrity, including temperature-controlled transportation. Additionally, the position analyses logistics costs, courier performance, and shipping quality metrics while supporting strategic logistics projects and ensuring adherence to customs, trade compliance, and regulatory requirements.

**Relationships**

This position will report to the Associate Director, Materials Management.

**Essential Functions**

- Primary point of contact for all activities regarding domestic Logistics for CMC Boulder
- Local shipping support for site Boulder
- Ensures prompt shipment related communications to key internal and external stakeholders
- Initiates, monitor, and complete shipments associated with research material, raw materials, drug substance, drug product
- Prepares all necessary data and confirmation of key milestones for shipments (departure, arrival, customs clearance, PODs, etc.)
- Ad-hoc support of international shipments and global trade compliance related activities
- Improve tracking system for shipments
- Leverage Novo Nordisk HQ processes and contracts where appropriate to improve the shipping process
- Management of outsourced inventory (Raw Materials, Drug Substance, Drug Product)
- Lead continuous improvement activities at outsourced CMOs
- Review and execution to discard expired material as needed at warehouses to ensure inventory optimization
- Drive the internal and external investigation of errors or non-conformances and prepare corrective and preventative action plans (CAPAs) in conjunction with QA and impacted departments
- Import/export experience – ensure trade compliance
- Ad-hoc filings with Customs broker and US Customs and Border Protection
- HTS classification and material valuations to ensure material is identified appropriately
- Incoterms to ensure shipment terms are appropriate
- Ad-hoc shipping and logistics projects
- Review and analysis of shipping costs and courier invoices
- Review and analysis of temperature-controlled shipments to maintain temperature requirements in transit
- Filing of temperature/quality events as needed
- Cross trained in global logistics responsibilities

**Physical Requirements**

Travel 10%. Travel to other Novo Nordisk locations, storage facilities, CMO’s may be required up to 10% of the time.

**Qualifications**

- Bachelor’s degree from an accredited university and 2+ years of experience in pharmaceutical or related industry required
- The position requires teamwork, organization and influencing skills with a strong focus on customer service for both internal and external stakeholders
- Ability to communicate effectively to all levels of the organization
- Excellent presentation skills
- Attention to detail
- Ability to effectively function and manage in a highly dynamic, fast paced work environment
- Strong organizational skills
- High-quality focus
- Strong business acumen
- Customer orientation
- Familiarity with import/export requirements for GMP and raw materials
- Excellent knowledge of logistics procedures
- CPIM/CLTD/CSCP certification a plus
- Familiarity with CFR 19, 7, 9, 42, 49, 50, 40 and 21
- Demonstrated ability to work independently and with cross-functional teams, including Supply Chain, CMC, Quality, Finance, R&D
- Proficient in Microsoft Excel

The base compensation range for this position is $83,400 - $127,500. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on September 15, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at [www.novonordisk-us/careers.com](<http://www.novonordisk-us/careers.com>).

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.

Colorado

Senior Engineer, MS&T

**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.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including **14 paid holidays**
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. 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**

Provide technical expertise and leadership to support technology transfer, process optimization and lifecycle management of manufacturing processes. Partner with cross-functional teams to ensure reliable, compliant and efficient operations while driving continuous improvement, process robustness and successful product delivery in alignment with Novo Nordisk's strategic objectives and quality standards.

**Relationships**

Reports to Manager or above.

**Essential Functions**

- Perform as a subject matter expert (SME) for a Drug Substance operation (e.g., production bioreactor processes, chromatography, tangential flow filtration, etc.)
- Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions
- Perform responsibilities associated with the evaluation, alignment and recommendation of equipment and process improvements
- Review daily processing data from GMP manufacturing to monitor process performance
- Authors and approves technical documents, such as batch records, protocols, bills of materials, sample plans, manufacturing campaign reports, operating procedures, etc
- Review technical and validation documents for accuracy and thoroughness
- Perform assessments on material changes as disclosed by suppliers
- Train others on manufacturing techniques and science/engineering principles
- Participate in client meetings offering technical support and act as the lead representative for MS&T
- Work cross functionally with Process Development, Manufacturing, Engineering, Automation, Quality Assurance, Quality Control, Supply Chain, Project Management, Validation, Facilities and other departments to effectively transfer and maintain processes in the facility
- Participate in and support strategic alignment across Biologics sites and the Bloomington site
- Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
- Lead and/or support the compilation of process data, including communicating project status, trend identification and delivering internal or client presentations
- Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency and competitiveness within the market
- Support the building of business case(s) for process improvement projects
- Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls and CAPAs including determination of product or process impact, root-cause analysis and corrective action identification
- Responsible for motivating, coaching and developing coworkers as a subject matter expert
- Act as a mentor to lower-level team members and Co-ops/interns
- Perform other responsibilities to support group, site and network-based initiatives, as required
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

**Qualifications**

- Bachelor's Degree in related field of study from an accredited university required and a minimum of four (4) years of relevant experience required
- In lieu of Bachelor's Degree with four (4) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of two (2) years of relevant experience required
- In lieu of Bachelor's Degree with four (4) years of experience, may consider a Doctorate Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required

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.

Indiana

Global Logistics Professional

**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**

Serve as a key member and logistics subject matter expert (SME) in Global Logistics & Distribution US (GL&D-US), with a focus on external warehousing operations and interfaces across internal and external stakeholders. Set direction and deliver results within own area of expertise by driving stakeholder alignment, process improvements, data-based decision making and resolution of more complex logistics and warehouse issues with few or no defined procedures in place. Ensure reliable, compliant and efficient warehouse execution in collaboration with the 4PL partner, freight forwarders, warehouses, customers and planners.

**Relationships**

Reports to Senior Manager.

**Essential Functions**

- Acts as a logistics process advocate and SME, coordinating priorities with internal and external stakeholders to remove barriers & enable optimal external warehouse execution
- Sets direction for alignment of processes, procedures and deliveries with PS external and internal warehouses, Freight Manager, Logistics Coordinators, Quality, Planners and other stakeholders
- Drives stakeholder management by maintaining clear, precise and timely communication; facilitating regular stakeholder meetings and proactively requesting feedback to improve processes and execution
- Coordinates and monitors critical shipment and warehouse activities with the 4PL partner, external warehouses and freight forwarders; escalates issues and recommends solutions as needed
- Challenges & optimizes external warehouse and distribution processes through a data-based approach, including defining or redefining processes and implementing sustainable improvements
- Handles more complex logistics, warehouse and quality issues, including unscheduled events, deviations, temperature deviations and process non-conformances; evaluates alternatives and drives resolution or escalation
- Supports audit readiness and compliance by performing periodic assessments, maintaining documentation of standard processes and ensuring corrective actions are communicated and implemented while also ensuring quality requirements are followed in performance of all duties
- Drives operational efficiency initiatives and continuous improvement across distribution and warehouse workflows
- Provides guidance to colleagues and stakeholders within own area of expertise; may work independently or with occasional guidance from manager or senior colleagues
- 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.

**Qualifications**

- Bachelor's Degree in Supply Chain Management, Economics, Engineering, Logistics or related field of study from an accredited university required and a minimum of two (2) years of Logistics, Supply Chain, External Warehousing (3PLs), or manufacturing experience in a regulated environment required; preferably in a pharmaceutical manufacturing environment.
- In lieu of BS Degree with two (2) years of experience, may consider an Associate Degree in Supply Chain Management, Economics, Engineering, Logistics or related field of study from an accredited college or university with a minimum of four (4) years of relevant Logistics, Supply Chain, External Warehousing (3PLs), or manufacturing experience in a regulated environment required; preferably in a pharmaceutical manufacturing environment
- Demonstrated experience working with external warehouses, 3PL/4PL partners and cross-functional stakeholders required
- Experience driving process improvement, practical problem solving and operational efficiency initiatives required
- Ability to analyse data and operational situations, evaluate known alternatives and recommend effective solutions to complex logistics or warehouse issues required
- Knowledge of US and EU regulations & guidelines; including application of GMP’s preferred
- Experience using Lean/Six Sigma methodologies and achieving sustainable process improvements preferred
- Strong communication skills across multiple organizational levels, including the ability to communicate technical information clearly in written, verbal and presentation formats, required
- Experience planning, organizing, managing execution, checking results & revising work plans preferred
- Computer expertise in MS Word, Outlook, Excel, PowerPoint, Access, SAP and novoGlow 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

Insmed Incorporated

Compliance Manager, Clinical Supply Chain

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

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

**About the Role:**

We’re looking for a Compliance Manager, Clinical Supply Chain on the Clinical Supply Chain team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Clinical Supply Chain, you’ll be responsible for managing compliance activities throughout the supply chain for assigned studies and projects ranging from phase I to phase IV clinical studies.

**What You'll Do:**

In this role, you’ll have the opportunity to ensure audit readiness for potential inspections to support the Clinical Supply Chain and Technical Operations and serve as main point of contact for compliance within the clinical supply on designated studies and projects function. You’ll also:

- Assist in developing the TMF index to better support the supply chain for assigned studies and/or programs
- Support IRT system design and UAT requirements for assigned studies. Perform UAT testing on IRT systems
- Support Change Control management activities within the clinical supply chain
- Coordinate with and manage external packaging, labeling and distribution vendors
- Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects
- Communicate relevant project information to internal and external stakeholders
- Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities
- Identify, report, manage and mitigate risks in the clinical supply chain
- Provide regular updates to the TMF as per regulatory requirements
- Understand anernal stakeholders to ensure supply compliance at each node within the supply chain
- Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics
- Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material
- Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements
- Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
- Responsible for managing the groups training curriculum

**Who You Are:**

You have a bachelor’s degree along with 5+ years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations.

You are or you also have:

- Ability to identify risks
- in process management and develop a solution-based approach that is operationally achievable
- Proficient with Microsoft Applications (Excel, PowerPoint, Word)
- Experience working with and/or managing external vendors
- Working knowledge of GMP, GCP and ICH guidelines
- Strong teamwork and collaboration skills
- Strong ability to handle multiple projects simultaneously
- Act with a sense of urgency

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

- MS Project and other computer software demand & supply related systems are a plus

**Where You’ll Work**

This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.

**Travel Requirements**

This role requires occasional global travel (approximately 5%–15%)

\#LI-BA

LI-HYBRID

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

New Jersey

Senior Manager, Clinical Supplier Quality

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

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

**About the Role:**

The Senior Manager, Clinical Supplier Quality is responsible for leading and overseeing supplier quality management activities supporting global clinical suppliers across development programs. You will serve as a key supplier quality partner to cross-functional stakeholders (e.g., Clinical Operations, Clinical Development, Biometrics, Bioanalytical, etc.) and external service providers to ensure compliance with global regulatory requirements and Insmed’s quality standards. You will administer the Supplier Management Program in partnership with DevQA, supporting supplier qualification, escalation management, quality data and performance trend monitoring, and quality agreement management for clinical suppliers supporting development programs.

**What You'll Do:**

In this role, you’ll have the opportunity to partner with DevQA to lead qualification, onboarding, risk assessment, and lifecycle management activities for clinical suppliers and service providers, ensuring compliance with global regulatory requirements and risk-based oversight principles, while assessing supplier capability, quality systems, and compliance against internal and external standards.

You’ll also:

- Collaborate and lead discussions with procurement, supply chain, DevQA and cross-functional SMEs to evaluate supplier performance history, support supplier selection, and execute qualification strategies for new and scope expansions of existing suppliers.
- Maintain and govern the approved supplier list and qualification records, ensuring appropriate risk-based controls are defined and applied throughout the supplier lifecycle in alignment with business and regulatory expectations.
- Maintain the supplier escalation programs to ensure that issues are getting elevated to the right levels at Insmed and within the Supplier’s organization to ensure we are addressing and solving issues effectively in a timely manner.
- Partner with DevQA to develop, manage, and continuously improve supplier performance monitoring frameworks for clinical suppliers in collaboration with the functional representatives, including KPIs, scorecards, and quality metrics, ensuring accurate risk-based scoring, timely completion, and appropriate control alignment.
- Support supplier quality event management and continuous improvement activities, including deviations, investigations, change controls, CAPAs, and development of supplier quality procedures, policies, templates, and governance frameworks.
- Analyze supplier quality data and performance trends, including deviations, CAPAs, audit findings, inspection outcomes, data integrity issues, and timeliness metrics, and facilitate, in collaboration with functional representative supplier governance forums and business reviews to drive remediation actions, corrective measures, and continuous improvement while maintaining accurate supplier records and approved supplier listings.
- Ensure supplier quality systems comply with global regulations, ICH guidelines, internal SOPs, and industry standards, while driving adherence to ALCOA+ data integrity principles and ICH Q9 risk management methodologies across outsourced activities.
- Provide support to inspection readiness activities for suppliers, and participating in Health Authority inspections (including FDA, EMA, MHRA, PMDA, and Health Canada).
- Support the audit program by conducting audits of suppliers and providing subject matter expertise through peer review, consultation on audit findings, and input on criticality assignment, ensuring that audit outputs remain objective, evidence based, and aligned with applicable regulatory standards.
- Own and manage the global clinical Quality Technical Agreement (QTA) program, including development, negotiation, execution, maintenance, periodic review, and renewal of Quality Agreements to ensure clear definition of GxP responsibilities, quality oversight, escalation pathways, data integrity expectations, inspection support obligations, and alignment with evolving regulatory and business requirements.

**Who You Are:**

You have aminimumof a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline as well as a minimum of 12 years of direct experience supporting GCP regulated activities.

You are or also have:

- Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
- Demonstrated experience with GCP Supplier oversight, GCP audits, Supplier qualification, CAPA management and Risk management.
- Quality Fundamentals: Deep understanding of ICH GCP guidelines, data integrity principles, and risk management methodologies (e.g., RBQM).
- Experience working within global clinical development environments.
- Strong working knowledge of global GCP regulations and guidelines, including FDA 21 CFR Parts 11, 50, 54, 56, and 312, ICH E6(R3), ICH E8(R1), EU Clinical Trials Regulation (EU) No. 536/2014, EU Annex 11, MHRA GCP guidance, EMA inspection expectations, and Health Canada clinical trial requirements.
- Certification in GC.
- Act in a highly organized manner with a strong attention to detail, clarity, accuracy, and conciseness.
- Proven influencing and negotiating skillset.
- Highly proficient in data analytics, critical thinking, and decision-making concepts.

**Nice to have (but not a must):**

- Experience supporting GLP regulated activities. Understanding of GLP regulations and laboratory compliance frameworks, including FDA 21 CFR Part 58, OECD Principles of GLP, EPA GLP requirements (where applicable), WHO GLP guidance, and data integrity and computerized systems expectations in laboratory environments.
- GLP auditing or clinical research.
- Prior people leadership experience. .

**WhereYou’llWork**

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

**Travel Requirements**

Up to 20% domestic and international travel based on supplier requirements.

\#LI-EG1

\#LI-remote

**Pay Range:**

$124,000.00-161,000.00 Annual

**Life at Insmed**

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

Highlights of our U.S. offerings include:

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

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

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

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

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

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

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

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

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

Nationwide

AbbVie

Strategic Site Partner

Company Description

**About AbbVie**

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

Job Description

**PURPOSE**

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

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

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

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

**Responsibilities:**

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

Qualifications

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

Additional Information

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>)

Illinois

Nurix Therapeutics

Senior Director, Head of Pharmacovigilance Operations

**Senior Director, Head of Pharmacovigilance Operations**

*Build and lead the pharmacovigilance operations that carry Nurix's growing clinical portfolio toward commercialization. You'll own the end-to-end ICSR model, safety systems, vendor oversight, and inspection readiness, with the chance to set strategy while staying hands-on and to build the function and team from the ground up.*

**Position Description**

**The Opportunity**

- Report to the Head of PV and define and execute the short- and long-term PVO strategy, goals, and operating model in alignment with the PV department and corporate objectives
- Grow, mentor, and develop the PVO team, setting priorities and ensuring coverage across a growing portfolio; partner with the Head of PV on departmental planning, headcount, and budget
- Provide PVO updates and escalate risks, issues, and compliance trends to PV and executive leadership as appropriate
- Oversee the end-to-end ICSR management framework (intake, processing, in-stream quality review, regulatory submission oversight, and retrospective quality review), ensuring timeliness, accuracy, and compliance with global regulations (21 CFR, EU GVP, ICH E2 series)
- Define, monitor, and report case processing metrics (KPIs/KQIs), drive root cause analysis and resolution of quality or timeliness issues, and oversee the drug safety mailbox
- Oversee SAE reconciliation with Clinical Operations and Data Management and Reference Safety Information (RSI) tracking and dissemination, and ensure PVO input into the safety content of clinical documents (protocols, ICFs, IBs/RSI, and CSRs)
- Ensure the integrity of safety data outputs from the Global Safety Database for aggregate reports, signal assessments, health authority requests, and other safety needs
- Oversee operational delivery of aggregate safety reports (e.g., DSUR, PBRER/PSUR), and partner with Medical Safety, Regulatory Affairs, and Biostatistics to support signal management and benefit-risk evaluation
- Own the strategy, validation, and lifecycle management of the Global Safety Database (e.g., Argus or equivalent) and related PV systems, including configuration, upgrades, and E2B gateway/electronic submission
- Lead system selection, implementation, and transition projects, including safety database migrations and vendor changes, and drive automation and process improvements such as reconciliation tools, intake portals, and reporting and analytics capabilities
- Lead oversight of outsourced PV activities and the CROs and vendors that support them, establishing governance, KPIs/KQIs, scorecards, and performance reviews, and driving corrective actions when performance falls short
- Own PV budget planning, forecasting, and invoice review, identifying opportunities for cost optimization without compromising compliance
- Lead the strategy and management of PV Agreements and Safety Data Exchange Agreements (SDEAs) with license partners, collaborators, and distributors
- Own PVO inspection readiness and launch readiness, and lead PVO participation in internal audits, vendor audits, and regulatory inspections, including front-room/back-room support and CAPA development and tracking through closure
- Develop, maintain, and continuously improve PVO and compliance-related SOPs, work instructions, and process documentation, and monitor the evolving global regulatory landscape so PVO processes adapt to new requirements
- Act as the senior PVO liaison to Clinical Operations, Data Management, Regulatory Affairs, Quality, Biostatistics, and Medical Safety, and support PV input into due diligence, in-licensing, and business development activities as needed

**What You’ll Bring**

- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required; an advanced degree (PharmD, MS, PhD, MBA) is preferred
- Minimum of 12 years of pharmacovigilance/drug safety experience in biotech or pharma, including in a leadership role managing PV operations and people
- Deep experience in PV operations and ICSR management across clinical development, with commercial readiness experience
- Demonstrated experience building, scaling, or transforming PV operations, ideally in a growing biotech environment
- Significant experience managing PV vendors and CROs, including KPI/KQI development, governance, and performance management
- Experience owning PV budgets, forecasting, and invoicing
- Experience leading or substantially supporting regulatory inspections and audits (FDA, EMA, or other health authorities), including CAPA management
- Experience with safety database implementations, upgrades, or transitions
- Proven experience authoring and governing SOPs, work instructions, and quality system documentation
- Experience negotiating and managing PVAs/SDEAs with license partners
- Strong leadership, coaching, and talent development skills, with the ability to build high-performing teams
- Excellent communication and influencing skills, with the ability to work effectively with executive leadership and cross-functional partners
- Strong analytical, organizational, and project management skills, with the ability to manage multiple products and priorities at once
- Quality and compliance mindset with strong attention to detail
- Comfort operating in a fast-paced, evolving environment, including through organizational change

**Salary Range:**  $ $288,100 - $325,700

*The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.*

**Location:** Remote or Onsite – Brisbane, CA

**Fit with Nurix Culture and Values**

- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view

**About Nurix Therapeutics**

*Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.*

California

Logistics Manager - ES US HUB

**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**

Oversee supplier performance, cost control and capacity planning across multiple external warehouses. Drive strategic implementation of global logistics initiatives, ensuring process harmonization and cost optimization. Lead enhancement projects, manage stakeholder relationships and translate business insights into actionable improvements. Handle escalation management, providing scenario planning and recommendations to maintain operational flow.

**Relationships**

Reports to Associate Director.

**Essential Functions**

- Own supplier relationships and accountability for external warehouse operations
- Develop annual budgets, monitor monthly costs and report deviations to senior management
- Lead supplier performance reviews and drive utilization improvements when constraints arise
- Manage execution of complex change projects, including capacity extensions and compliance initiatives (GxP, legal requirements)
- Lead tactical supplier management initiatives and ensure timely delivery of enhancements
- Drive adoption of new ways of working, focusing on cost optimization and process harmonization across warehouses
- Oversee outsourcing initiatives to Global Business Services (GBS) and clarify roles and responsibilities
- Lead Data driven improvement initiatives
- Collaborate closely with internal stakeholders to capture business insights and translate them into cost and budget implications
- Participate in regular stakeholder meetings and align warehouse operations with changing business needs
- Review and update of Internal Agreements
- Monitor operational flow and escalating capacity challenges to management
- Prepare scenario analysis with pros, cons and cost implications, recommending optimal solutions
- Entail the capability to independently tackle complex issues and make pivotal decisions, involving numerous stakeholders within Novo Nordisk
- Demand a substantial level of self-reliance, excellent prioritization abilities and a dedicated focus on upholding high-quality standards
- Follow all safety & environmental requirements in the performance of duties
- Other duties, 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, Economics, Engineering, Logistics or related field of study from an accredited university required and a minimum of four (4) years of logistics experience with external warehouses (3PLs) in a regulated environment required; preferably in a pharmaceutical or manufacturing environment
- In lieu of BS Degree with four (4) years of experience, may consider an Associate Degree in Supply Chain Management, Economics, Engineering, Logistics or related field of study from an accredited college or university with a minimum of six (6) years of logistics experience with external warehouses (3PLs) in a regulated environment required; preferably in a pharmaceutical or manufacturing environment
- Logistics Management experience preferred
- Demonstrated good leadership skills required
- Strong communication skills (both verbal and written) and strong stakeholder management required
- Strong logistical, analytical, strategic thinking & problem-solving skills required
- Demonstrated scenario planning experience required
- Demonstrated strong quality mindset required
- Ability to create & manage projects with a lean data-driven mindset required
- Demonstrated collaboration across all levels of management teams required
- Advanced logistics or transportation competencies obtained through relevant training or experience required
- Intermediate knowledge of Lean/Six Sigma methodologies to achieve sustainable process improvements preferred
- Excellent organizational skills & attention to detail required

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.

Metrology Technician II/III (DPM Expansions)

**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**

Calibrate measuring equipment on schedule & in accordance with corporate & local requirements. Provide troubleshooting, problem solving & project support for measuring equipment site wide. Support training for lower-level team members.

**Relationships**

Reports to the Supervisor/Manager.

**Essential Functions**

- Calibrate & repair temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency measuring equipment
- Lead, conduct, & participate in systematic problem solving. Support cross-functional investigations in all customer areas
- Participate in metrology related projects in the department
- Accurately & legibly record all activities in appropriate documentation. Write work orders
- Lead calibration activities as scheduled, supported by the Metrology Lead
- Review documentation for accuracy & completeness
- Process confirm calibration activities are performed per standards
- Operate & handle calibration working standards with care & expertise
- Address safety, quality, staffing, or personnel issues & escalate to Supervisor if necessary
- Attain & maintain aseptic clean room certification
- Identify deviations per proper procedures for measuring equipment
- Participate in systematic problems solving
- Provide support to process owners for measuring equipment
- Execute work according to schedule & department plan
- Evaluate measuring equipment performance & respond to potential issues
- Contribute to process confirmations
- Maintain training qualifications on time. Support training others as required
- Support other department roles as needed
- Follow all safety and environmental requirements in the performance of duties
- 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. Ability to be on feet for up to a 12-hour shift. May required 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. Occasionally performs critical job functions in extremely cold work environment. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. 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**

- Associate’s degree in related engineering or science discipline from an accredited university required
- May consider a High School Diploma (GED) with six (6) years of relevant metrology/calibration work experience and six (6) years of thorough understanding of instrumentation & control systems required
- Minimum of four (4) years of relevant metrology/calibration work experience required
- Minimum of four (4) years of thorough understanding of instrumentation & control systems required
- Competencies in the following areas: Calibration, Instrumentation & Controls, Electro-Mechanical systems & Electronics required
- Ability to calibrate process and utility instrumentation required
- Experience using electronic calibration management systems such as SAP, Blue Mountain RAM, ProCal, MAXIMO, etc required
- Able to read & apply schematics, wiring diagrams & other technical documents required
- Basic computer skills required
- High level of organization in task management preferred
- Demonstrates logical planning for task execution & follow-up preferred
- Demonstrates a systematic approach to problem solving & troubleshooting required

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.

Process Professional I

**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**

Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Provide process solutions for routine to moderate complexity issues. Support training for junior team members.

**Relationships**

Reports to Manager.

**Essential Functions**

- Work with production and QA to provide in depth deviation investigations and root cause analysis
- Drive continuous improvements via Lean tools
- Provide training on process and procedure changes
- Identify and implement process needs and improvement opportunities for routine to moderate complexity issues
- Responsible for collection of data for periodic reviews and reporting
- 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 20% of the time (% can change on a case-by-case basis based on the role).

**Minimum Qualifications**

- Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required
- May consider an Associate’s degree from an accredited university with a minimum of two (2) years of manufacturing experience required
- May consider a High School Diploma (GED) with a minimum four (4) years of manufacturing experience required
- Minimum of one (1) year of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment
- Excellent written communication skills required
- GMP knowledge required
- Basic investigation and systematic problem-solving experience required

**Preferred Qualifications**

- Manufacturing experience preferred
- General knowledge of change control and Quality Management System (QMS) systems preferred
- Relevant electronic manufacturing system experience preferred (ex: SAP, PAS-X, etc)
- Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred
- Exposure to regulatory audits/inspections 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.

Process Engineer I - 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**

Improve/develop systems & equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus and Standards "Gatekeeper".

**Relationships**

Reports to Manager, Senior Manager or Senior Project Manager.

**Essential Functions**

- Coach & mentor peers as well as Shopfloor personnel
- Support technical development of Shopfloor personnel
- Employ advanced cLEAN® tools within the main areas of problem solving, project & change management
- Lead cross-functional process improvements
- Develop plans to improve the performance of a process or set of systems, using green belt concepts
- Develop & manage project budget for improvements for a process or set of systems
- Support event response activities
- Support implementation of better practices & participate in sharing knowledge across all OFP sites for improvement projects
- Maintain & establish standards for procedures & maintenance plans
- Support global OFP collaboration initiatives
- Follow all safety and environmental requirements in the performance of duties
- 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**

- Bachelor’s degree in engineering or related field from an accredited university required with one (1) year of engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification/equivalent preferred
- May consider Associate’s degree in engineering or relevant field of study from an accredited university with two (2) years of engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification /equivalent required
- May consider High School Diploma (GED) with four (4) years engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification/equivalent required
- Three (3) years of engineering experience in maintenance, design, process improvement, or Six Sigma Green Belt certification or equivalent preferred
- Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA) & Reliability Centered Maintenance (RCM) 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.

Sr. Director, Global Brand & Portfolio Management

**Job Summary:**

The Sr. Director, Global Brand & Portfolio Management is accountable for defining and executing Seqirus's global portfolio vision and strategy across current influenza brands (inline), pipeline assets, and adjacent vaccine opportunities. This role leads a team responsible for global product portfolio strategy and positioning, global brand and lifecycle management, and new product planning and launch readiness. In partnership with cross-functional stakeholders, the role provides commercial and portfolio leadership to inform evidence generation priorities, pricing and market access strategies, and portfolio investments. Working in close partnership with R&D and cross-functional stakeholders, the role ensures alignment from research through commercialization, advances high-value strategic investments, and drives portfolio decisions that maximize mid- to long-term growth, value creation, and public health impact. As a member of the Global Commercial Strategy & Planning (GCS&P) Leadership Team, the Sr. Director serves as a key strategic leader across the global vaccines organization.

*This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid*

**Principal Accountabilities**:

**Global Portfolio Strategy & Brand Leadership**

- In partnership with R&D and GCS&P’s External Partnerships team, lead the development and execution of Seqirus's global Portfolio Development Strategy (PDS), ensuring alignment with the broader Business Unit (BU) Strategy.
- Partner with GCS&P’s Strategy & Business Planning team on development/evolution of aforementioned BU Strategy, including overseeing development of strategic imperatives and objectives as well as cross-functional tactical plans. Aim is to provide strategic oversight and vision for initiatives that create value and drive improvement for Seqirus.
- Direct a team responsible for global product strategy across marketed vaccines, pipeline assets, and launch products.
- Define product portfolio positioning, co-positioning strategies, above-brand narratives, evidence themes, lifecycle priorities, and portfolio investment recommendations.
- Oversee lifecycle management strategies that drive both short- and long-term growth of commercialized brands.
- Lead global launch planning and commercialization readiness for pipeline assets, including launch sequencing, business case development, and resource prioritization.
- Oversees and guides continued global launch planning for aTIVc, including maximizing the portfolio opportunity across Fluad and aTIVc, refining the launch sequencing strategy, advancing business cases for key investments, and leveraging the Glocal brand marketing model (global to local division of activities) to drive efficiencies.
- Direct geographic expansion strategies and evaluate market entry and exit opportunities across the portfolio.
- Provide portfolio and commercial input into long-term pricing strategies, value propositions, and market access planning in partnership with Global Market Access & Pricing for both inline and pipeline products
- Support evaluation of external partnerships, business development opportunities, and portfolio expansion opportunities which are led by GCS&P’s External Partnerships team.
- Oversee development and continuous improvement of global claims, messaging, communications, and scientific narratives.
- Ensure product portfolio strategies are informed by market research, competitive intelligence, customer insights, epidemiological trends, and evolving vaccine market dynamics.
- Manage team budgets and identify opportunities to improve operational efficiency and return on investment.

**Portfolio Development, Strategic Decision-Making & Governance**

- Lead the commercial evaluation and strategic development of internal vaccine programs from early development through commercializationin partnership with R&D, GCS&P’s Strategy & Business Planning team, GCS&P’s External Partnerships team and various cross-functional team members.
- Direct assessment of key development milestones, including clinical strategy, evidence requirements, comparator selection, timing, and commercial readiness.
- Identify portfolio opportunities, risks, data gaps, and investment priorities; guide cross-functional teams in developing plans to address them.
- Support and/or lead governance processes and planning forums to ensure timely decision-making, transparency, accountability, and strategic alignment.
- Uphold portfolio-level decision frameworks, escalation pathways, and implementation roadmaps for strategic priorities.
- Develop and advance business cases for major internal product investments, clinical development programs, and portfolio expansion opportunities, partnering with regions/markets and cross-functional team members.
- Influence senior leadership on prioritization, resource allocation, funding decisions, and long-range investment strategies.
- Represent the commercial function in governance forums and ensure Seqirus business unit priorities are reflected in CSL enterprise strategic decisions.
- Own or oversee relevant global commercial governance processes and continuous improvement initiatives.

**Cross-Functional Leadership, Alignment & Value Optimization**

- Oversee and/or lead cross-functional and global brand team governance across commercial, R&D (regulatory, clinical development, medical affairs), CEA, finance, operations and supply chain, and external partnerships/business development stakeholders.
- Align regional and functional strategies with overall portfolio objectives and resolve competing priorities across brands and functions.
- Lead strategic discussions with global and regional commercial leaders to advance lifecycle opportunities and pipeline development plans.
- Foster collaboration across regions to ensure consistent execution of portfolio strategies while addressing market-specific needs.
- Influence senior leaders and cross-functional partners to secure alignment on key commercial and development decisions.
- Aim to optimize portfolio investment allocation and resource prioritization to maximize mid- to long-term portfolio value and return on investment.
- Integrate evidence generation, publication planning, and scientific communication strategies to support a unified portfolio narrative.
- Lead scenario planning, competitive assessments, and risk mitigation efforts across the portfolio.
- Establish strong partnerships with external agencies, consultants, industry organizations, and key strategic partners.

**Project Work:**

The Sr. Director will lead or support strategic initiatives and assessments related to the evolving global vaccine landscape, including:

- Evaluation of changing market dynamics and competitive threats.
- Development of commercialization and defense strategies for emerging technologies and combination products.
- Partnering with CEA, assessment of policy, immunization guidelines, and governmental changes impacting portfolio growth.
- Strategic evaluation of adjacent vaccine opportunities and business development investments.
- Advancement of high-priority business cases supporting portfolio expansion and mid- to long-term growth.

**Scope/Accountability**:

This role has global responsibility across the Seqirus product portfolio including inline/marketed products and pipeline or launch assets. The position provides strategic leadership for portfolio development, lifecycle management, launch planning, commercialization strategy, and governance activities that influence hundreds of millions of dollars in current and future revenue. The role oversees significant budgetary investments, manages external agencies and consultants, and partners closely with R&D to ensure commercial perspectives are incorporated throughout the development process. Success requires alignment of multiple geographies, functions, and resources around business unit priorities and strategic objectives.

**Impact/Influence/Liaison**:

This position requires extensive influence across global and regional organizations, including Commercial Operations, R&D (Clinical Development, Medical Affairs, Regulatory), CEA, Legal, External Partnerships/Business Development, Finance, Operations and Supply Chain, and Senior Leadership. The individual must independently align stakeholders around portfolio priorities, investment decisions, development strategies, and commercialization plans. The role regularly influences senior leadership decisions, develops strategic business cases, and establishes processes and policies that support portfolio management activities globally.

**Key Relationships**:

Internal

- Global Commercial Strategy & Planning (GCS&P) Leadership Team
- Commercial Operations and Regional Commercial Leadership
- Research & Development (Clinical Development, Medical Affairs, Regulatory)
- CEA
- Global Market Access & Pricing
- External Partnerships/Business Development
- Finance
- Operations/Supply Chain
- Legal and Compliance

External

- Industry associations
- Policy organizations
- Scientific and commercial consultants
- Market research agencies
- Promotional agencies

**Decision Making**:

This role is responsible for addressing complex strategic, operational, and investment decisions with significant commercial impact. Decisions influence portfolio direction, development priorities, lifecycle investments, launch strategies, geographic expansion, and resource allocation across the business. The individual must rapidly assess opportunities and risks, develop strategic recommendations, align stakeholders, and oversee execution against approved plans.

Accountable for:

- Product portfolio strategy and positioning
- Lifecycle priorities
- Above-brand narratives and scientific platforms
- Evidence generation priorities
- Investment allocation recommendations
- Geographic expansion strategies
- Market entry and exit recommendations

Consulted on:

- Brand messaging
- Pricing strategy
- Commercial investment decisions

**Innovation**:

The role operates in a highly dynamic and competitive vaccine environment requiring both incremental and transformational innovation. The Sr. Director must identify emerging opportunities, anticipate market changes, develop differentiated strategies, and create innovative solutions to complex business and public health challenges. Success requires curiosity, strategic thinking, strong prioritization skills, and the ability to inspire action across a global organization.

**Travel Requirements:**

- 10-20% - Primarily Global

**Knowledge, Skills & Competencies:**

- Executive leadership and change leadership capabilities
- Strong strategic thinking, business acumen, and portfolio management expertise
- Systems-thinking mindset with the ability to connect brand strategies to portfolio outcomes
- Deep understanding of pharmaceutical and vaccine commercialization, lifecycle management, and product development
- Demonstrated expertise in strategic planning, governance design, investment prioritization, and resource allocation
- Strong financial acumen and business case development skills
- Data-driven decision-making utilizing clinical, real-world evidence (RWE), HEOR, market, and competitive insights
- Exceptional stakeholder management and influence skills, including the ability to lead without direct authority
- Outstanding communication, presentation, and executive engagement capabilities
- Proven success leading cross-functional global teams and building alignment across diverse stakeholders
- Ability to thrive in ambiguity and lead organizations through change; and Strong analytical, problem-solving, and prioritization skills.

**Minimum Education Requirements**:

- Bachelor of Science with MBA or MS (Pharmaceutical or basic sciences) preferred

**Minimum Experience Requirements:**

- Minimum 12 years of experience in the pharmaceutical industry, including at least 8 years of experience in one of the various pharmaceutical functions, e.g. commercial, sales, or marketing, vaccines highly preferred 5+ years in portfolio strategy or multi-brand leadership.
- Minimum 7 years of experience in managing personnel, project management, leading cross-functional global teams
- Proven success in growing established products, particularly across regions or through global capacity
- Intercultural experience and ability to lead in a complex and rapidly changing business environment, preferably 7+ years
- Skills: Strategic framing, evidence strategy, financial modeling, governance design, stakeholder influence, executive communication
- Strong knowledge of business processes within pharmaceutical industry, e.g. forecasting, strategic planning, budgeting, project management, etc.
- Proficiency in MS Excel and PowerPoint and other Microsoft applications.

The expected base salary range for this position at hiring is $287,000 - $352,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position in Summit, NJ and Waltham, MA as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

\#LI-Hybrid

**About CSL Seqirus**

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world, CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

**Watch our ‘On the Front Line’ video to learn more about CSL Seqirus**

Eagle Analytical

Analytical Chemistry Supervisor- Raw Material

**Job Details**

**Description**

What We're Looking For

The Supervisor, Analytical Chemistry: Raw Material Testing is responsible for providing scientific, logistical, and personal leadership within the analytical chemistry team focused on raw material testing. This individual will leverage their expertise to ensure the quality and efficiency of all raw material analyses, drive continuous improvement, and expand the laboratory’s capabilities in support of pharmaceutical manufacturing and compliance requirements.

What You Will Do

- Oversee, schedule and perform routine and non-routine analytical testing of raw material samples according to established procedures and regulatory guidelines; ensures testing is completed within required timelines.
- Reviews and interprets test results for accuracy and compliance; promptly notifies management of any unexpected or out-of-specification results and leads investigations and troubleshooting with minimal supervision.
- Supervises the maintenance, calibration, and troubleshooting of analytical equipment (e.g., HPLC, GC, FTIR, UV-Vis Spectrophotometer, TOC analyzer, Wet Chemistry testing equipment) used for raw material testing to ensure all instruments are operating within calibration and performance standards; coordinates repair and preventive maintenance activities as needed.
- Ensures team members maintain proficiency with all relevant equipment, systems, and standard operating procedures (SOPs) specific to raw material analysis.
- Keeps current with advances in analytical techniques, instrumentation, and regulatory expectations for raw material testing, with an emphasis on pharmaceutical industry standards.
- Provides leadership and support across all raw material testing workstations, facilitating cross-training and backup coverage as needed to ensure uninterrupted laboratory operations.
- Ensures meticulous and compliant documentation of all raw material testing activities, results, and investigations in accordance with cGMP and data integrity requirements.
- Leads the development, revision, and review of SOPs and laboratory documentation specific to raw material testing, ensuring timely updates to align with regulatory and operational changes.

Who You Are

- Bachelor’s, Master’s or Doctorate degree in Analytical Chemistry or related science field, with directly related experience of 3-4 years in an analytical chemistry laboratory within pharmaceutical industry
- Hands-on experience with sample preparative chemistry and wet chemistry analysis per compendial monograph procedures
- Understanding of instrumental analysis procedures utilized in a modern chemistry laboratory
- Demonstrated competence with computer applications and programs related to laboratory applications
- Knowledge of sampling methods and quality control systems.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

**Qualifications**

**Skills**

**Preferred**

Active Listening

*Expert*

Analytical Instrumentation

*Advanced*

Detail Oriented

*Expert*

Deductive Reasoning

*Advanced*

Good Judgement

*Expert*

**Behaviors**

**Preferred**

Leader: Inspires teammates to follow them

Team Player: Works well as a member of a group

Innovative: Consistently introduces new ideas and demonstrates original thinking

Thought Provoking: Capable of making others think deeply on a subject

:

**Motivations**

**Preferred**

Self-Starter: Inspired to perform without outside help

Goal Completion: Inspired to perform well by the completion of tasks

Flexibility: Inspired to perform well when granted the ability to set your own schedule and goals

Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization

:

**Education**

**Required**

Bachelors or better in Analytical Chemistry or related field.

**Experience**

**Licenses & Certifications**

**Preferred**

Certification in HPLC

Equal Opportunity Employer

Texas

US Sales Operations Associate Director & Excellence

**The Opportunity:**

Reporting to the VP, US Sales, the Associate Director, Sales Operations serves as a strategic business partner responsible for optimizing the effectiveness, efficiency, and execution of the U.S. field sales organization.

This role leads and orchestrates the development and deployment of sales

operating strategies, performance management frameworks, business processes, and field engagement initiatives that enable the achievement of commercial objectives. You will ensure field leadership and sales representatives have access to actionable insights,

streamlined processes, effective tools, and clear priorities required to maximize customer engagement and business performance.

You will partner extensively with Insights & Analytics, Marketing, Market Access, Finance, Field Reimbursement, Training, Compliance, and IT to drive

executional excellence, enhance sales force effectiveness, accelerate strategic initiatives, and foster a high-performing sales culture.

As a trusted advisor to Sales Leadership, this individual identifies opportunities for continuous improvement, anticipates business needs, and leads cross-functional initiatives that strengthen organizational capability and support growth objectives.

**The Role:**

**_Sales Performance Management & Strategic Analytics_**

- Lead the business review process, including monthly, quarterly, and annual performance reviews with Sales Leadership, providing actionable insights and recommendations to drive performance improvement.
- Partner with Insights & Analytics to establish and maintain a single source of truth for sales reporting, dashboards, and key performance metrics.
- Monitor business trends, identify risks and opportunities, and provide strategic recommendations to senior leadership.
- Drive adoption and utilization of performance measurement tools that enable data-driven decision-making across the sales organization

**_Operational Excellence & Process Optimization_**

- Drive operational excellence by optimizing sales processes, reducing administrative burden, and improving field productivity.
- Partner with cross-functional stakeholders to evaluate and enhance sales force effectiveness, capabilities, and execution.
- Manage sales operations tools, processes, and governance to support achievement of commercial objectives.
- Serve as the operational lead for the planning, prioritization, and execution of field initiatives.
- Working in partnership with field leadership, the individual establishes
  clear ownership, timelines, success measures, adoption monitoring and follow- through for field-facing priorities.
- Maintain the national sales calendar and coordinate cross-functional activities to ensure appropriate sequencing and prioritization of initiatives.
- Partner with Sales Training and Meeting Planning to support successful execution of national meetings, POAs, ACMs, and other field-facing programs.

**_Sales Leadership & Cross-Functional Partnership_**

- Act as a trusted advisor and primary operational partner to the VP of US Sales, National Sales Directors, and Sales Managers.
- Collaborate across Marketing, Market Access, Finance, HR/PE&O, Training, Compliance, and IT to ensure successful execution of commercial strategies.
- Facilitate leadership team meetings, communications, and follow-through on key business priorities.
- Partner closely with the Executive Assistant supporting the VP of U.S. Sales to coordinateleadership priorities, key meetings, communications and timely follow-through on organizational commitments.

**_Communications, Engagement & Organizational Effectiveness_**

- In partnership with Sales Leadership team and communications, drive clear, consistenttimely communication to the field organization.
- Support initiatives that foster a high-performing and engaged sales culture, including town halls, All Hands meetings, recognition programs, and leadership communications.
- Serve as a point of escalation for operational issues and field support needs.

**_Strategic Projects & Continuous Improvement_**

- Lead and support strategic initiatives that enhance operational effectiveness, field execution, organizational capability, and employee engagement.
- Identify opportunities to simplify processes, improve business outcomes, and strengthen the overall effectiveness of the sales organization.
- Manage special projects and change initiatives aligned to commercial priorities and organizational goals.

**Skills and Experience:**

- Bachelor degree in a scientific or business field
- 10 years' pharmaceutical, biotech or healthcare industry experience with special focus on sales and/or marketing, sales or sales leadership strongly preferred
- Experience leading teams, projects, or business initiatives within sales, sales leadership, training, marketing, commercial operations, or related functions.
- Demonstrated ability to influence cross-functional stakeholders and drive alignment without direct authority.
- Experience translating business objectives into actionable plans and operational execution.
- Strong organizational, project management, and communication skills with the ability to manage multiple priorities in a fast-paced environment.
- Experience presenting business insights and recommendations to leadership audiences.

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Pennsylvania

Automation Supplier Execution

The Automation Supplier Execution Lead is accountable for establishing and governing the local technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems, including but not limited to PCS, MES, PLC, Lab Instrument and SCADA platforms. This role will align with global governance for the technical aspects of supplier relationships, ensuring that master service agreements, quality plans, service agreements, maintenance agreements, partner KPIs, and platform lifecycle commitments are monitored at each site for each local partner. Additionally, this role is responsible for executing and managing the local shared services operating model for OT partners, including local adoptions of enterprise services management and embedded engineering services.

- Role that this position reports to: Site Automation Head
- Role/s that report to this position: This role is an individual contributor

**Responsibilities:**

1. **Local OT Partner Governance & Shared Service Model**

- Execute against the local framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.
- Define and monitor roles, responsibilities, and interfaces between partners, shared services, and internal teams to avoid overlap and gaps.
- Ensure partner governance practices (costings, reviews, escalations, approvals) are consistently monitored.
- Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.

2. **Enterprise Services & Shared Services Structure**

- Monitor the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.
- Coordinate with global and site stakeholders to ensure services are right-sized, sustainable, and cost-effective.
- Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.

3. **Contracting, MSAs & Project Templates**

- Own and maintain local adoption master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.
- Execute project contracting templates for use across all OT platforms and project types.
- Partner with Above-site E&M, Legal, Procurement, and functional contract owners to ensure contracts clearly define scope, deliverables, compliance, and pricing structures.
- Periodically review and refresh contract terms to reflect evolving business needs, risk posture, and partner performance.

4. **Partner Project Delivery Management**

- Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.
- Establish expectations for partner project governance, documentation, testing, and handover to operations for all partner-led projects.
- Capture and feed partner related project lessons learned into global standards, templates, and partner governance processes.

5. **Platform Lifecycle & Enterprise Alignment**

- Ensure partner and shared service agreements support the full lifecycle of OT platforms (introduction, expansion, upgrades, decommissioning).
- Align local partner responsibilities with platform roadmaps for PCS, MES, OSI PI, LIMS, and other OT enterprise applications.
- Coordinate with OT Architecture, I&T, and platform owners to confirm lifecycle activities are contractually defined, resourced, and scheduled.
- Track local execution of lifecycle activities and drive corrective actions when deviations from standards, timelines, or quality expectations occur.

6. **Performance Management & Strategic Relationship Leadership**

- Monitor local KPIs, scorecards, and review cadences for strategic OT partners and shared services.
- Lead periodic performance and business reviews with partners and shared service leaders to address issues, risks, and opportunities for improvement.
- Act as the primary escalation point for structural performance concerns or contractual disputes related to OT services.
- Foster long-term, collaborative relationships with strategic partners and shared service teams that promote innovation, efficiency, and reliability across the OT ecosystem.

**Education:**

- Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.

**Experience:**

- 10+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
- Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
- Experience writing, executing, and monitoring automation contract deliverables
- Ability to work across a range of countries and cultures
- Strong project management skills and experience in engineering projects within biopharma manufacturing.
- Functional knowledge of cGMPs and manufacturing operations in regulated facilities.

**Competencies:**

- Automation & Execution Systems Expertise
- Project Management
- Regulatory Compliance
- Strategic Planning
- Stakeholder Engagement
- Strategic innovation
- Delivering Enterprise Results and Value Orientation

*The expected base salary range for this position at hiring is $138,000 - $164,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Director of Manufacturing Engineering and Maintenance

**Position Purpose:**  Provide an overview of the responsibilities of the position by providing a summary of the most critical aspects and duties of the position.

The Head of Manufacturing Engineering & Maintenance is a strategic leader responsible for the reliability and lifecycle management of manufacturing assets. This role oversees Calibration & Metrology Engineering, Manufacturing Maintenance, Reliability Engineering, Production/System Owner Engineering, and Shutdown Planning & Scheduling. Key responsibilities support critical operations, including fractionation, bulk production, and packaging, while ensuring equipment readiness and compliance with regulatory standards in the biopharmaceutical sector. The position also requires strong skills in labor relations to foster collaboration within a unionized workforce.

**Reporting Relationships**:

**Role that this position reports to:**  Engineering & Maintenance Site Head

**Role/s that report to this position:**  Engineers, Maintenance, Calibrations, Shutdown Planner

**Main Responsibilities and Accountabilities:**

1. **Engineering Leadership**

- Develop and implement the site engineering and maintenance strategy aligned with CSL enterprise objectives, ensuring optimal asset performance and lifecycle management
- Lead and develop a high-performing organization, fostering a culture of accountability, safety, and continuous improvement
- Direct all aspects of manufacturing engineering and maintenance, including technical support, project management, emergency response, on-call, troubleshooting, and corrective, preventive/predictive maintenance.
- Supports the development and implementation of multi-year strategic plans, capital investment roadmaps, and operational readiness programs for all global sites
- Additionally, you will support capital projects throughout their entire lifecycle, from conception and planning to execution and commissioning, ensuring that each project aligns with organizational objectives and is completed successfully.

2. **Strategy Reliability & Asset Management Vision**

- Develop and execute enterprise-level reliability strategies (RCM, FMEA, PdM, CMMS optimization)
- Enhance the accessibility of assets, maximize operational uptime, and optimize the overall cost performance throughout their lifecycle.
- Analyze equipment failures and lead root cause analysis (RCA) and corrective actions
- Establish asset health monitoring and performance metrics

3. **Continuous Improvement**

- Drive continuous improvement initiatives leveraging Lean, Six Sigma, and reliability-centered methodologies
- Explore and pinpoint areas where automation can enhance efficiency, digitization can streamline processes, and predictive maintenance can optimize equipment performance.
- Additionally, create and monitor KPIs for engineering activities, along with comprehensive dashboards to visualize and track these metrics effectively.

4. **Capital Projects & Technical Execution**

- Support site capital projects, including equipment installation and AMP upgrades,
- Provide oversight for planning and execution of site shutdowns and turnarounds, ensuring adherence to scope, schedule, cost, and safety requirements
- Ensure proper design, qualification, and handover of assets to engineering and maintenance operations

5. **Quality Management & Regulatory Compliance**

- Ensure quality management procedures within manufacturing engineering and maintenance, with a focus on cGMP and GEP requirements, are implemented.
- Leads the site's manufacturing engineering and maintenance organization, ensuring assets and services are in compliance with GMP and regulatory standards and product filings.
- Oversee deviation management, investigation of deviations, and establishment of corrective and preventive actions for critical systems.
- Represent the local manufacturing engineering and maintenance function in regulatory inspections, audits, and ensure areas within the area of responsibility remain audit-ready.

6. **Cross-Functional Collaboration**

- Partner with Manufacturing, Quality, MS&T, EHS, and Supply Chain to support production goals, resolve technical challenges, and improve process performance
- Engage with global and regional leadership, peers at other sites to align manufacturing engineering and maintenance strategies with broader business goals.

7. **Team Leadership & Development**

- Lead, mentor, and develop a diverse, cross-functional team of engineers, maintenance professionals, and quality specialists on site.
- Foster a positive, equitable, and inclusive working environment, emphasizing CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Develop succession plans and talent pipelines to ensure organizational resilience and leadership continuity.

8. Perform other duties as assigned by the supervisor, members of the Global Leadership Team, or other authorized leaders in support of evolving business needs and cross-functional collaboration.

**Position Qualifications and Experience Requirements:** Provide the hiring requirements for the specified position, including educational, experiential, and competency requirements.

**Education**

- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biochemical, or related discipline) is required

**Experience**

- **12+ years** of engineering experience in Biotech, Pharma, or regulated life sciences.
- **8+ years** leading engineers or technical teams
- Strong understanding of GMP, validation, and regulatory expectations
- Experience with reliability engineering, maintenance strategies, and CMMS systems
- Knowledge of Six Sigma/Lean principles is a plus.
- Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable)
- Familiarity with automation and digital systems
- Financial experience with high-level budgetary responsibilities is required
- Strategic thinker with the ability to translate complex engineering challenges into actionable programs

**Competencies**

- Strong analytical and problem-solving skills.
- Excellent communication abilities.
- Innovation Leadership
- Technical Expertise in Asset Management
- Data-Driven Decision Making
- Change Leadership & Transformation
- Cross-Cultural Collaboration
- Financial Acumen & ROI-oriented mindset
- Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

*The expected base salary range for this position at hiring is $199,000 - $244,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.*

**About CSL Behring**

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](<https://www.csl.com/careers/your-well-being>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Senior Principal Engineer, Plastics Molding — Pharmaceutical Manufacturing & Medical Devices

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

Position Overview

Full-time | Hybrid

The Senior Principal Engineer, Plastics Molding provides enterprise-level technical leadership for plastic injection molding and blow molding technologies supporting pharmaceutical manufacturing, medical devices, biologics, healthcare, and closely related regulated products. This role leads complex engineering initiatives across the product and process life cycle, advancing robust, compliant, scalable molding solutions through close partnership with internal stakeholders and external suppliers.

Key Responsibilities

- Lead medium- to large-sized, complex molding engineering projects from concept and design through procurement, qualification, validation, and sustained support.
- Develop and implement technically sound injection- and blow-molding solutions that meet product, process, quality, cost, and regulatory expectations.
- Provide technical direction on equipment, tooling, automation, resin selection, process development, inspection strategy, and manufacturing readiness.
- Conduct risk assessments, manage life-cycle costs, and communicate technical recommendations, project status, and risk-based decisions to management.
- Support supplier selection, supplier performance, and technical issue resolution for molds, equipment, automation, and related services.

Technical and Functional Accountabilities

- Apply deep knowledge of plastics processes, resins, injection molding equipment, blow molding, tooling, and inspection procedures to optimize process capability and product quality.
- Plan and execute FMEAs, design of experiments (DOE), dimensional analysis, statistical process control (SPC) analysis, factory acceptance testing (FAT), equipment and process qualification, and validation activities.
- Translate design controls, quality-system expectations, regulatory requirements, and applicable ISO requirements into practical engineering deliverables and manufacturing controls.
- Lead or support tooling and automation design, procurement, qualification, and supplier management; evaluate technical proposals and acceptance criteria.
- Use metrology and dimensional data to investigate variation, establish process controls, and drive effective corrective technical actions.
- Maintain working familiarity with CNC equipment, wire EDM, surface finishes, grinders, hand tools, and 3D CAD platforms including SolidWorks, Creo/ProE, and AutoCAD.

Candidates are considered based on relevant qualifications, skills, and experience. The role welcomes a diverse range of backgrounds and perspectives consistent with applicable equal employment opportunity principles.

Leadership and Collaboration

- Serve as a recognized technical resource, providing clear, evidence-based guidance on molding technology, manufacturability, risk, quality, and life-cycle decisions.
- Partner effectively with cross-functional teams and external collaborators, including manufacturing, quality, engineering, procurement, suppliers, and service providers.
- Influence technical alignment across stakeholders, facilitate resolution of complex issues, and enable timely execution in a regulated operating environment.
- Communicate complex engineering concepts clearly to technical and non-technical audiences and advise management on options, tradeoffs, and recommendations.

This is a hybrid role based in North Chicago, Illinois. Work may include collaboration across office, manufacturing, supplier, and project environments.

Travel up to 40% may be required to support suppliers, equipment and tooling activities, factory acceptance testing, qualification, validation, and cross-functional project needs.

\#LI-AL1

Qualifications

- Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Engineering, Science, or a related field; equivalent technical experience may be considered.
- 8-10 years of significant engineering and/or operational experience, preferably in pharmaceutical manufacturing, medical devices, biologics, healthcare, or another closely related regulated industry.
- 3+ years of plastic injection molding and/or blow molding design and process-support experience.
- Demonstrated knowledge of molding equipment, plastics processes and resins, tooling, inspection procedures, SPC analysis, and applicable regulatory and ISO requirements.
- Demonstrated experience with tooling and automation design; procurement and qualification; supplier management; FMEA, DOE, dimensional analysis, FAT, validation, design controls, metrology, and quality systems.

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>)

Technician, Manufacturing III (M-F)

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

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Responsibilities

Shipping finished materials.

- Maintaining inventory levels.
- Sampling of in process and raw materials.
- Running glass washer / autoclave.
- Buffer / media preparation.
- Equipment preparation (CIP / SIP).
- Cell culture (from vial thaw to production scale).
- Column chromatography.
- Tangential flow filtration.

\#LI-JW1

Qualifications

- Associates degree in science (or equivalent experience).
- Preferred 4+ years area specific relevant experience.
- Preferred Bachelor's Degree with 2+ years area specific relevant experience.
- Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks.
- Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.
- Normally receives little instruction on daily work, general instructions on newly introduced assignments.
- May be informal team leader.

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 roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors 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 isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable 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 absolutediscretion, 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>)

Tris Pharma

Washroom Technician

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S.** 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.

**Located in Monmouth Junction, New Jersey, Tris has an immediate opening for Washroom Technicians on all 3 shifts:**

**1st shift. Days/Hours are M-F, 6:00 AM – 2:00 PM**

**2nd shift Days/Hours are M-F, 2:00 PM – 10:00 PM**

**3rd shift Days/Hours are M-F, 10:00 PM – 6:00 AM**

The Washroom Technician is responsible for supporting and assisting the Manufacturing and Operations teams in the cleaning of manufacturing equipment and instrumentation in accordance to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards. She/he also provides and monitors the continuous flow of product and components to all manufacturing areas to ensure adequate supplies are organized and in stock, as needed.

**ESSENTIAL FUNCTIONS**

Primary duties/responsibilities

· Under direct supervision of the Manufacturing Supervisor and/or Manufacturing Technician Group Lead, provides continuous flow of product and components to all manufacturing; Ensures adequate supplies are organized and in stock, as needed

· Ensures manufacturing equipment is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standards

· Supports and assists with daily cleaning functions, as needed (vaults, floors, hallways, etc.)

· Assists in general manufacturing activities, as needed

· Precisely follows work orders and specifications

· Adheres to all plant safety policies and procedures

Requirements

*Minimum education and years of relevant work experience*

High school diploma or equivalent

**KNOWLEDGE/SKILLS/ABILITIES REQUIRED**

· Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.

· Excellent verbal and written communication and skills

· Fluent in English (verbal and written)

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

· Physical requirements - Manufacturing based position

· Ability to lift up to 50 lbs

· Ability to use Personal Protective Equipment (PPE)

· Ability to stand for extended periods

**Special knowledge or skills PREFERRED**

· Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes

· Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs

Anticipated pay rate: $21/hour. Additional $1.50/hour for 2nd shift differential, $2.50/hour for 3rd shift differential. Pay rate 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 experience.

Additional benefits: In addition to base salary, full-time employees (does not pertain to temporary 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