Quality

Regeneron Pharmaceuticals, Inc.

Manager Quality Risk Management

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Were hiring a Manager Quality Risk Management (QRM) to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the implementation of the QRM Governance process globally at Regeneron Industrial Operations & Product Supply (IOPS) sites, ensuring compliance with global regulations and standards set forth by governing regulatory and accrediting agencies. They will also support other departments and project teams in meeting quality and business objectives as they relate to GxP risk management.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**Discover your role:**

- Works with all departments across IOPS to identify risk-based tools and methodologies to support efficiency and compliance related improvements at both a local and global level
- Formulate risk management principles, methods and tools, and documents in appropriate Regeneron policies, procedures, and reports
- Ensure that staff are educated and trained (cross sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters
- Lead data driven risk assessments (risk identification, analysis, and ranking)
- Provide ongoing collaboration, engagement, and education to cross-functional teams members in the application and compliance of risk assessment and mitigation processes
- Implement QRM program to ensure risk assessments are conducted at required frequencies and manage the overall process, tasks, and communications
- Communicate the outcome from quality risk management activities and periodic site-wide reviews
- Works with the QRM Management team to integrate quality risk management concepts and philosophies into the overall Quality System
- Develop, coach, and support direct reports and broader team to build a sustainable QRM organization
- Manages a team to ensure proper maintenance of risk documents and support of new risk assessments for IOPS
- Represent Regenerons approach to QRM during regulatory inspections and partner audits
- Represent QRM team as subject matter expert in risk management governance processes

**This role requires:**

- BS/BA in Biological Sciences, Chemistry or Biochemistry or a related field; or equivalent combination of education and experience
  - Associate Manager Quality Risk Management: 6+ years of experience
  - Manager Quality Risk Management: 7+ years of experience
  - Level will be determined based on experience
- Previous people leadership/ supervisory experience
- Experience with recombinant protein manufacturing or development of manufacturing processes

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$92,200.00 - $176,000.00

New York

Sr. Specialist Data Quality & Insights

**Build our future together**

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, while redefining our understanding of health.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Specialist - Data Quality & Insights to join our Data Management team in Hyderabad. In this hands-on role, you will lead the reconciliation, validation, and quality oversight of external vendor data across multiple clinical data types. You will use Python, SQL, ETL tools, and data-quality reporting solutions to identify and resolve discrepancies, improve vendor data quality, strengthen inspection readiness, and support reliable clinical decision-making across the portfolio.

**When & where**

Hyderabad, India

**Discover your role**

- Perform end-to-end reconciliation of external vendor data, including Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarker data, against Medidata Rave and the Clinical Data Lake.
- Develop and maintain Python- and SQL-based reconciliation scripts, ETL pipelines, and automated data-quality checks for incoming external vendor datasets.
- Investigate, document, and coordinate the resolution of data discrepancies with Data Acquisition teams, vendors, and cross-functional partners, tracking issues through closure and CAPA processes where applicable.
- Execute study-specific data-quality timelines and checkpoints to ensure external data is validated and reconciled in line with protocol schedules and regulatory expectations.
- Implement and enhance Flask/Python-based reporting solutions used to publish data-quality reports and automated QC outputs for clinical and scientific stakeholders.
- Create and maintain vendor quality metrics and KPIs, including error rates, reconciliation timeliness, and protocol deviation trends, and communicate findings during vendor operational meetings.
- Develop data-quality dashboards and vendor scorecards that support inspection readiness, audit traceability, and continuous improvement.
- Partner with GD-IT and Data Acquisition teams on the ingestion, transformation, staging, and mapping of raw vendor data within the Clinical Data Lake.

**This role requires**

- Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or a related field.
- 4-6 years of hands-on experience in clinical data management, external data reconciliation, or clinical data quality within the pharmaceutical or biotechnology industry.
- Deep working knowledge of external clinical data types, such as Central Lab, Imaging, PK/PD, Cytokines, eCOA, and Biomarkers, including flow cytometry, genomic, or proteomic datasets.
- Hands-on expertise in Python and SQL for data analysis, automation, reconciliation scripting, ETL pipelines, and data-quality checks. SAS experience is also relevant.
- Experience working with cloud data-lake platforms such as Dremio, Snowflake, or similar technologies.
- Proficiency with EDC systems, particularly Medidata Rave, and experience reconciling vendor data against clinical systems.
- Strong knowledge of CDASH standards, protocol schedules of events, protocol amendments, and study-specific data-mapping requirements.
- Experience partnering with global and cross-functional teams, with strong problem-solving, communication, and stakeholder-management skills.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Other Non-US

QA Specialist (On the Floor)

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Specialist position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

**Where & Where:**

- Location: Rensselaer, New York, United States
- Work model: Wednesday - Saturday, 1st shift, 6:00 AM - 4:30 PM

**Discover your role:**

- Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
- Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
- Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
- Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
- Review, edit, or approve Regeneron controlled documents
- Review and approve investigations associated with product or processes
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
- Supervising direct reports
- Participates with employee training to ensure that all requirements are met.
- Performs, minimally, monthly performance feedback meetings with direct reports.

**This role requires:**

- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
- Principal QA Specialist: 6+ years of relevant experience
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing
- Level will be determined based on experience

**This role may be for you if you**:

- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to stand for periods of time when performing tasks on the floor

**Gowning and Environment:**

- Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Specialist position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

**Where & Where:**

- Location: Rensselaer, New York, United States
- Work model: Sunday - Thursday, 3rd shift, 10:00 PM - 8:30 AM

**Discover your role:**

- Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
- Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
- Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
- Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
- Review, edit, or approve Regeneron controlled documents
- Review and approve investigations associated with product or processes
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
- Supervising direct reports
- Participates with employee training to ensure that all requirements are met.
- Performs, minimally, monthly performance feedback meetings with direct reports.

**This role requires:**

- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
- Principal QA Specialist: 6+ years of relevant experience
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing
- Level will be determined based on experience

**This role may be for you if you**:

- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to stand for periods of time when performing tasks on the floor

**Gowning and Environment:**

- Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

Quality Compliance Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Quality Compliance Specialist to join our Quality Assurance team. This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**What you'll do:**

- Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
- Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
- Build strong relationships with end users, serving as a go-to resource on standard change control processes
- Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures
- Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
- Support regulatory and customer audits as a subject matter expert on change control
- Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
- Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
- Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

**Lets find out if were a fit**:

- Requires B.S in life sciences or related field; may substitute proven experience for education requirement
  - Associate Quality Compliance Specialist: 0-2+ years of experience
  - Quality Compliance Specialist: 2+ years of experience
  - Level will be determined based on experience

**Thrive today. Grow tomorrow.**

- Student loan paydown program & tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $110,000.00

Senior Manager, Stewardship Operations, Quality & Evidence

**Build our future together:**

The Senior Manager, Stewardship Operations, Quality & Evidence is responsible for the continuous data-quality monitoring capability for enterprise planning data, turning ratified standards and business rules into active checks, routed flags, and decision-ready evidence. This role owns the monitoring, escalation-routing, and reporting cadence that keeps data quality issues visible before they reach a finished report, and compiles the evidence base the Data Stewardship Council and senior leadership use to review conformance and prioritize future stewardship work. Reporting to the Director, Data Stewardship, this position operationalizes the monitoring and evidence pillar of the enterprise stewardship operating model, working in close partnership with the Sr. Manager, Enterprise Stewardship & Standards, whose ratified definitions and RACI assignments this role monitors against.

**When & where:**

- Location: TarryTown NY, or Warren NJ
- Travel percentage: 10%

**Discover your role:**

- Operate and continuously improve enterprise data-quality monitoring in Planisware (leveraging the Data Quality Audit capability), configuring checks to reflect currently ratified definitions, business rules, and RACI assignments.

- Monitor planning data continuously against core data-quality dimensions completeness, accuracy, consistency, uniqueness, validity, and timeliness and route flagged issues directly to the accountable plan owner for resolution at the source.

- Compile and maintain the monthly data-quality summary presented to the Data Stewardship Council, highlighting recurring issues, trends by function, and items requiring escalation.

- Produce the quarterly data-quality trend report for senior leadership, providing the evidence base used to prioritize future stewardship and quality initiatives.

- Maintain a system of record (audit trail) documenting monitoring results, flagged issues, remediation status, and outcomes, to support auditability and knowledge continuity across review cycles.

- Partner with Digital & Technology to keep monitoring tooling configured to current ratified standards, distinguishing tooling or system defects from underlying data-content issues and routing each to the correct owner.

- Track and report adoption and conformance by role Data Creator, Curator, Enabler, and Consumer to identify where an agreed expectation is not being met and where follow-up is needed.

- Support the Sr. Manager, Enterprise Stewardship & Standards, and the Director, Data Stewardship, in assembling monitoring evidence for decision records and escalation packages when a flagged finding surfaces a cross-functional disagreement requiring Council resolution.

- Track and report on monitoring coverage (e.g., share of required or active milestone codes under active monitoring) and issue closure rates, providing input to the broader stewardship roadmap and operating-model maturity.

- Collaborate with system Business Process Owner (e.g., Planisware, Planview) and Program, Portfolio Management, and Program Management leads to ensure monitoring reflects current planning-system configuration and usage.

**This role requires:**

- Working knowledge of drug development, clinical/program planning, and portfolio management terminology and processes.

- Demonstrated experience operating or administering data-quality monitoring, audit, or observability capabilities (e.g., automated data-quality checks, exception and alert routing, conformance dashboards), ideally within a data governance or data management framework.

- Skilled in defining and tracking data-quality metrics against recognized dimensions (e.g., completeness, accuracy, consistency, uniqueness, validity, timeliness) and translating monitoring output into clear findings.

- Strong evidence-based reporting skills, with a proven ability to compile monitoring results into decision-ready summaries for audiences ranging from function leads to senior leadership.

- Excellent written communication skills, including the ability to produce clear, concise operational and trend reporting for governance and leadership review.

- Familiarity with Planisware (or comparable project/portfolio planning systems) and its data-quality and reporting capabilities; ability to partner effectively with technical teams on tooling configuration without owning the underlying build.

- Strong analytical and problem-solving skills, comfortable working with large operational datasets to identify patterns and root causes.

- Ability to work independently and collaboratively in a matrixed organization, partnering with Data Governance, Data Analytics & Data Science (DA&DS), Digital & Technology, and domain data stewards.

*Preferred Qualifications:*

- Experience with data observability or data-quality tooling (e.g., Monte Carlo, Collibra, Informatica) is a plus.

- Data management or governance certification (e.g., CDMP) and/or PMI Project Management Professional (PMP) is preferred, but not required.

**EDUCATION**

- Bachelor's Degree required.

**REQUIRED LICENSES & CERTIFICATES**

- None required. Data management/governance certification (e.g., CDMP) and/or PMP preferred.

**MINIMUM YEARS OF EXPERIENCE**

- 8+ years in data management, data quality/observability operations, business analysis, or related roles, including experience operating monitoring or reporting capabilities and producing evidence for governance bodies. Biopharma / drug development experience preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$134,400.00 - $219,200.00

Executive Director, Quality Assurance Microbiology

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director, QA Microbiology who leads the strategy, design, and operational execution of Regeneron's GMP contamination control program across aseptic and low-bioburden biopharmaceutical manufacturing operations. This individual provides technical and operational direction to ensure robust environmental control, sterility assurance, and microbial contamination risk management across the network, driving compliance with global regulatory expectations for sterile and non-sterile product manufacturing. This position guides functional areas in support of compliance and business objectives, ensures the contamination control strategy remains current with evolving industry and regulatory expectations, and serves as the key liaison with operational microbiology and manufacturing subject matter experts across the lines of business.

**When & where:**

- Location: East Greenbush, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**Discover your role:**

- Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) grounded in sound microbiological science, aseptic processing principles, and applicable quality, regulatory, and legal requirements.
- Provide expert vision in environmental monitoring (EM) programs, cleanroom classification, personnel qualification, gowning practices, and aseptic process simulation (media fill) performance across manufacturing sites.
- Influence root cause investigations and risk assessments for microbial excursions, sterility failures, and environmental monitoring deviations, ensuring timely, science-based corrective and preventive actions.
- Monitor contamination control program performance using meaningful operational metrics (e.g., EM trends, excursion rates, media fill success rates) and demonstrate a commitment to continuous improvement.
- Embed quality risk management (QRM) toolssuch as FMEA and contamination risk mappingwithin microbiology and aseptic operations to proactively identify and mitigate contamination vectors.
- Maintain current expertise in evolving regulatory expectations (e.g., EU Annex 1, FDA Aseptic Processing Guidance, USP \<1116\>, PIC/S) and proactively integrate emerging requirements into the contamination control program.
- Apply quality and risk management tools to make timely, science-based decisions that protect patient safety and product sterility.
- Partner closely with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Lab functions to translate contamination control strategy into robust, compliant aseptic practices on the floor.
- Serve as the senior microbiological and contamination control decision-maker, exercising sound judgment under pressure to ensure product safety and efficacy.
- Represent Regeneron as the subject matter authority on contamination control and sterility assurance to internal leadership, regulatory agencies, and corporate/external partners.
- Translate contamination control vision and strategy into executable, resourced action plans across the manufacturing network.
- Ensure the Contamination Control Strategy is transparent, well-documented, and that the broader organization is engaged and accountable for its execution.
- Establish high standards for performance management and accountability to achieve microbiological, sterility assurance, and organizational objectives.

**This role requires:**

- Bachelors degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related scientific discipline (advanced degree preferred), or equivalent combination of education and experience, and the following amount of progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control, including significant leadership experience in aseptic manufacturing environments, for each level:
  - Senior Director 15+ years
  - Executive Director 18+ years
  - Level will be determined based on experience

- Deep operational expertise in aseptic processing and low-bioburden manufacturing, including cleanroom design/classification, HVAC airflow principles, personnel and material flow, gowning qualification, and aseptic technique.
- Demonstrated hands-on ownership of a Contamination Control Strategy (CCS), including environmental monitoring program design, trending, and risk-based EM site selection.
- Strong working knowledge of aseptic process simulation (media fill) design, execution, and failure investigation.
- Expert-level understanding of global regulatory expectations and guidance, including EU Annex 1 (2022 revision), FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, USP \<1116\>, PIC/S, and ISO 14644.
- Proven track record leading root cause investigations, deviation management, and CAPA for microbial contamination events, sterility test failures, and environmental excursions.
- Demonstrated ability to apply Quality Risk Management tools (FMEA, fishbone, risk mapping) to contamination control and microbiological decision-making.
- Experience representing microbiological/contamination control positions directly to health authorities during inspections (FDA, EMA, MHRA) with a strong inspection track record.
- Demonstrated success partnering cross-functionally with Manufacturing, Facilities/Engineering, QA Operations, and Microbiology Labs to translate strategy into floor-level execution.
- Strong people leadership experience, including building and developing high-performing technical teams and driving accountability across a matrixed organization.
- Excellent judgment and composure in high-stakes, time-sensitive decision-making affecting product disposition and patient safety.
- Executive presence and communication skills suited to representing the company with regulators, corporate partners, and senior leadership.

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$203,000.00 - $399,400.00

Assoc QC Analyst (Day 1)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **QC Analyst** to join our **Quality Control Laboratory** team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & Where:**

- **Shift Requirements:**  24/7
- **Location:**  Raheen, Limerick, Ireland
- **Other Requirements:**  Work in a regulated laboratory environment while adhering to all safety and quality procedures

**What youll do:**

- Perform chemical and/or biological testing on raw materials, in-process materials, finished products, stability samples, and research samples.
- Gather, analyze, and document testing data to support quality and compliance requirements.
- Review laboratory results and identify, investigate, and escalate quality anomalies when appropriate.
- Calibrate and verify laboratory instruments and equipment to ensure reliable and accurate testing.
- Write, revise, and follow Standard Operating Procedures (SOPs), test methods, and laboratory documentation.
- Support analytical method validation, method transfer activities, and continuous improvement initiatives.
- Maintain laboratory supplies and ensure a safe, organized, and inspection-ready workspace.
- Collaborate with cross-functional teams to support product quality and regulatory compliance.

**The environment and physical rhythms of this role:**

- This role requires working in a laboratory environment, including wearing appropriate personal protective equipment and following gowning requirements.
- May involve standing for extended periods, handling laboratory equipment, and performing repetitive tasks.
- Requires adherence to safety, quality, and regulatory procedures at all times.

**Lets find out if were a fit:**

- Bachelor's degree in Life Sciences or a related scientific discipline.
- Experience in a laboratory, quality control, or regulated environment preferred.
- Strong attention to detail with the ability to accurately document and review data.
- Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements is advantageous.
- Effective communication and collaboration skills.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (hourly)**

16.42 - 25.59

Temp Assoc QC Analyst

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Temp QC Analyst** to join our Sample Management team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Raheen, Limerick, Ireland
- Shift: 24/7
- This is a 12-month contract position
- This is an onsite role supporting laboratory operations

**What you'll do:**

- Perform chemical and biological testing on raw materials, in-process materials, finished products, and stability samples
- Review and document analytical data, ensuring compliance with quality standards and regulatory requirements
- Support method validation, technology transfer activities, and continuous improvement initiatives
- Maintain laboratory equipment, supplies, and documentation in accordance with GMP requirements
- Collaborate with internal teams and external partners to support quality and operational excellence

**The environment and physical rhythms of this role:**

- Thrive working in a laboratory environment with a strong focus on quality and compliance
- Demonstrate strong attention to detail and accuracy when performing testing and reviewing data
- Balance multiple priorities while meeting timelines and maintaining regulatory standards
- Work effectively both independently and as part of cross-functional teams
- Participate in ongoing training and development activities

**Lets find out if were a fit:**

- Requires BS/BA in Life Sciences or related field, or an equivalent combination of education and experience
- For Associate QC Analyst: 0-2 years of relevant experience
- For QC Analyst: 2+ years of relevant experience, preferably in a GMP-regulated pharmaceutical or biotechnology environment
- Strong attention to detail and ability to work effectively in a team-based laboratory environment

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Novo Nordisk

Senior Quality Assurance Area Specialist I (QA or IT & Automation)

**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**

Responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

**Relationships**

Reports to Manager, Quality Assurance.

**Essential Functions**

- Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
- Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers’ ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
- Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
- Support evaluation of the quality level during the project by performing spot checks of validation documentation
- Perform activities related to Batch review & release
- Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
- Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
- Review & approve change control requests
- Review & approve deviations
- guidance to departments regarding quality & related activities
- Participate & provide input to root-cause analysis
- Participate in process confirmations & quality oversight
- Authorized person according to Novo Nordisk Quality Manual
- Other accountabilities, as assigned.

**Physical Requirements**

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your 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. May require the ability to work in loud noise environments with hearing protections.

**Qualifications**

- Bachelor's Degree in Life Sciences, Engineering, or related field required
- Minimum of five (5) years of experience within the pharmaceutical industry required
- Good Knowledge of cGMP manufacturing & production processes & how to apply required
- Good Knowledge of the Batch review Processes required
- Good Knowledge of quality management systems required
- Good Knowledge of quality oversight & on floor production support required
- Strong knowledge level in cGMP’s & validation required
- Strong knowledge in Quality Management Systems required
- Must be ability to perform tasks independently, accurately & within defined time frames required
- Ability to willingly work with customers/stakeholders in a cooperative manner required
- Strong written & verbal communication skills required
- Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
- Proven expertise in planning & organizing tasks preferred
- Willingness to assist others in developing plans in a cross-functional environment preferred
- Innovative approach to establishing priorities 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

Legend Biotech

QC Stability Coordinator (Intern)

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

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

Legend Biotech is seeking a **QC Stability Coordinator** as part of the **Technical Development** team based in **Somerset, NJ.**

**Role Overview**

Legend Biotech is seeking an Intern as part of the Analytical Development team based in Somerset, NJ to assist in the planning, execution, and documentation of stability studies to support pipelines. This role provides hands- on experience in laboratory operations, stability data trending, documentation, and compliance with regulatory guidelines.

**Key Responsibilities**

- Oversee the scheduling, pulling, and testing of stability samples across internal and external QC labs.
- Maintain accurate and contemporaneous records in Quality Management Systems and in a verified database for internal stakeholders.
- Conduct stability trending analysis from analytical results for review by QC manager or SME. Assist in preparing charts, graphs, and preliminary reports and be able to deliver within the targeted timeline.
- Participate in team meetings and provide updates on assigned tasks

**Requirements**

- Currently enrolled in a U.S. college or university program (Chemistry, Biology, Pharmaceutical Sciences, or related field).
  - Someone in their Sophomore or Junior year prefered.
- Basic understanding of laboratory procedures and scientific data handling.
- Motivated, highly organized, strong attention to detail and muti-tasking skills.
- Proficiency in Microsoft Excel and/or SMARTSHEET. Power BI as a plus.
- Excellent written and verbal communication skills. Ability to work independently and as part of a team.
- Hybrid onsite schedule, at least 3 days a week on Mon, Tue and Thu.

\#Li-RP1

\#Li-Hybrid

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

**Work Authorization & Employment Eligibility**

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

**EEO Statement**

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

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

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

New Jersey

QA Warehouse Specialist III

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

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

Legend Biotech is seeking a **QA Warehouse Specialist III** as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The QA Warehouse Specialist is an exempt level position with responsibility of supporting Warehouse activities related to material receipt, handling and release as well as incoming and release of patient material/final product at the Raritan, NJ Legend CAR-T manufacturing site.

**Key Responsibilities**

- Be part of the quality team responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment.
- Reviews, inspects, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.
- Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.
- Conducts routine housekeeping checks of the Warehouse and supporting areas.
- Conducts routine reviews of warehouse documents and logbooks to ensure that GDP are being adhered to.
- Ensures that all materials are in the proper location and under the appropriate storage conditions.
- Make appropriate quality decisions in support of warehouse activities.
- Ensure that cycle counts are accurate and performed in a timely manner in accordance to the procedures.
- Review and inspect documentation in support of Final Product Shipments.
- Generates inspection reports and non-conformances for failures as required.
- Scanning, filing and archival of QA related documents.
- Updates supervisor of work status or problems with recommendations for improvement or correction.
- Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Other duties will be assigned, as necessary

**Requirements**

- 0-4 years of relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
- Proficient in the use of quality systems such as SAP.
- Experience working with cell therapy is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practice is required.
- Excellent written and oral communication skills are required.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

\#Li-BZ1

\#Li-Onsite

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

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

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

Pay Range (Base Pay):

$96,267 - $126,351 USD

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

**Work Authorization & Employment Eligibility**

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

**EEO Statement**

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

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

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

Frederick National Laboratory for Cancer Research

Mechanical Maintenance Millwright

**Mechanical Maintenance Millwright**

Job ID: req4724

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Facilities Maintenance and Engineering (FME) mission is to support the NCI at Frederick in their mission to cure cancer and AIDS. FME is responsible for the physical campus - its research laboratory space, administrative space, the infrastructure that supports the buildings, and the landscape that surrounds them. In addition, we are responsible for managing, planning, designing, and construction management of renovations at the FNLCR.

**KEY ROLES/RESPONSIBILITIES**

- Assembling and installing machines then testing them to make sure they are working correctly
- Examines equipment in operation to determine if adjustments are adequate or if repair is necessary
- Installs a variety of laboratory machinery and equipment as required
- Must work in full compliance with the approved safety regulations
- Performs preventive maintenance to identify and correct potential issues, removing worn out pieces and lubricating mechanical parts
- Basic mechanical principles used in maintaining vacuum pumps, air compressors, air handlers and a variety of industrial equipment
- Performs other related duties as assigned by a responsible authority. Disassemble and repair a variety of industrial equipment; read blueprints and work orders; follow standard practices and craft techniques in installing, maintaining, and repairing industrial equipment
- Works independently using standard trade techniques
- Subject to 24-hour call-in for emergency repairs

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirement, a minimum of five (5) years of mechanical-related experience is required
- Working knowledge of mechanical technical skills to allow them to effectively read documents such as specifications, machine manuals, and blueprints
- Proficient in troubleshooting techniques to solve machine issues
- Mathematical skills and strong attention to detail
- Ability to be a team player due to constant interactions with similar employees and stakeholders such as Engineers, Managers, and Part Vendors, amongst others
- Must have the ability to routinely lift and carry up to 50 lbs.; climb stairs and ladders; work involves bending, stooping, and working in confined areas; potential exposure to particulates, vapors, or noisy environment
- Must have and maintain a valid State Driver's License issued by the state in which the candidate resides. Must have no more than 3 demerit points in the previous twelve (12) months or five (5) demerit points in the preceding thirty-six (36) months as determined by the Leidos Biomed Use of Government Owned or Leased Vehicles Policy
- Experience with construction safety practices
- Must be available to respond to occasional after-hours emergency repair needs, including participation in an infrequent 24-hour on-call rotation
- This position is considered safety-sensitive and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program
- Ability to obtain and maintain a security clearance

**JOB HAZARDS**

- This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance
- This position is subject to working with or has the potential for exposure to animals(s) and/or animal material(s)
- This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

55,400.00 - 81,600.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

Eli Lilly and Company

Senior Director, Counsel, Diagnostics & Medical Devices (USA Remote Role)

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

**Senior Director, Counsel, Diagnostics & Medical Devices**

**Key Objectives/Deliverables:**

Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units as assigned, on diagnostic and device issues related to their commercial strategy (e.g., lab-developed tests, in vitro diagnostics, imaging agents, medical devices, and software/digital health).

This attorney will counsel business unit marketing, medical affairs, and related teams on commercial legal matters related to diagnostics, including FDA labeling and advertising requirements, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust, unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions (including OUS) — with particular depth in fraud and abuse, promotional, and antitrust matters.

Depending on the business unit and programs assigned, additional subject matter may include laws and regulations pertaining to pharmaceutical promotion and other medical device and digital health matters.

In this role, this attorney will work collaboratively with legal colleagues in other areas, business units, and affiliates, and must be proactive and adept in providing practical counsel in a fast-paced, dynamic, and innovative environment.

**Responsibilities:**

Activities in this role may include the following:

- Providing legal counsel and education on FDA labeling and promotional matters for diagnostic products and medical devices, as well as pharmaceuticals

- Providing diagnostics and device-related fraud and abuse, promotional, and antitrust counsel to the Neuroscience Business Unit and potentially across multiple business units, as assigned

- Collaborating with sales and marketing colleagues to advise on device or diagnostic-related patient support and consumer programs consistent with healthcare fraud and abuse laws

- Educating business partners on potential legal implications of proposed marketing tactics related to diagnostics and medical devices

- Advising on potential legal implications related to interactions with third parties relevant to diagnostics and devices, including diagnostics companies and software/digital health companies

- Counseling on sponsored testing programs

- Participating as a core member of leadership teams responsible for diagnostics- and device-related brand and/or product strategies

**Basic Requirements:**

- Bachelor's degree and JD.

- Licensed to practice law in at least one of the 50 States

- Minimum of 7 years of relevant legal experience, practicing as a member of a law firm with a nationally recognized practice in medical devices and in vitro diagnostics, in-house at a medical device, laboratory or diagnostics company law department, in-house in a pharmaceutical or biotechnology company's law department, or a combination of the foregoing. In-house experience is preferred.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.*

**Additional Skills and Expertise:**

- Deep knowledge and understanding of FDA laws and regulations pertaining to diagnostics and medical devices (e.g., Medical Device Amendments of 1976 to the FDCA, CLIA, state laws)

- Demonstrated knowledge of device and pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational companies

- Demonstrated experience with fraud and abuse, promotional, and antitrust matters

- Experience evaluating sponsored testing programs for compliance

- Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information

- Familiarity or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals is a plus

- Ability to manage multiple priorities in a fast-paced and evolving environment

- Demonstrated ability to assess and help business colleagues manage risks in a highly regulated environment
- Sound judgment and issue-spotting ability

- Strong interpersonal skills and ability to partner well with others

- Committed to teamwork and collaboration

- Excellent oral and written communication skills, with a demonstrated ability to present complex information accurately and concisely to influence others at all levels of management

- Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in the delivery of legal services

**Other Information:**

Some travel required (circa 10% - US and possibly limited international).

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

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

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

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

$199,500 - $321,200

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

\#WeAreLilly

Indiana

BioMarin Pharmaceutical Inc.

(CW) Technical Manager, QA (Contract)

:

Responsible for owning and continuously improving one or more global Supplier Quality Management

(SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable

for the overall efficiency/effectiveness of the Supplier Change Notification (SCN)

process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager

will be accountable for developing, executing associated processes, programs, and

initiatives to ensure overall supplier performance for GMP Material Suppliers to support

BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the

implementation of a risk-based approach to the management of SCNs and lead efforts for

periodic review and updates. They will establish the governance structure and controls to

ensure the SCN and ASL processes are consistently applied across the supply base,

ensure the health of the SQM process is continuously evaluated, and drive continuous

improvement.

Cross functional collaboration with external and internal partners and stakeholders across

different sites and functions is key for success in this role. This includes collaboration

with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global

Manufacturing Sciences and Technology (GMSAT), and other site functions.

This position requires knowledge and experience with supplier management processes.

The person must possess technical expertise and business acumen in the areas of

responsibility.

RESPONSIBILITIES

▪ Lead Quality-related reviews, cross-functional process teams, serving as a subject

matter expert for Supplier Change Notifications.

▪ Lead all quality aspects for the management of BioMarin’s Approved Supplier

List.

▪ Establish process to monitor SCNs through key performance indicators (KPIs),

trend analysis, and regular reviews, identifying and leading opportunities for

improvement.

▪ Serve as the Business Process Owner for SCN and ASL process(es), proactively

monitoring and maintaining the health of the process and subprocesses, driving

continuous improvement efforts, and sustaining compliance with current and

evolving global health authority requirements and regulations.

▪ Review and approve Supplier Change Notifications in the QMS.

▪ Make decisions and act with authority to carry out actions as applicable.

▪ Collaborate with external/internal global and site stakeholders to identify, define,

and implement opportunities for improved SCN process workflows, while

aligning the process with organizational goals and strategies. Promote knowledge

sharing and the best practices.

▪ Develop, implement, and communicate quality policies and procedures to ensure

consistency across the network and alignment with global processes.

▪ Support implementation of program enhancements to SCN and ASL processes.

▪ Provide SME support to site inspections, global inspections, and related

observation responses.

EDUCATION

▪ BA/BS in life sciences or related field

EXPERIENCE

▪ 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or

other highly regulated industry

▪ Knowledge and experience in GMP and GDP global regulations, principles,

concepts, practices, and standards.

▪ Prior experience and knowledge in Supplier Quality, Compliance, or a

combination of experience such as Manufacturing, Quality, and Regulatory

required. Knowledge in international regulatory landscape preferred.

▪ Demonstrated ability to work effectively in a matrix environment and drive

results through “influence” as well as direct management.

▪ Organizational and management skills, with ability to effectively plan, schedule,

execute, and track complex projects.

▪ Excellent interpersonal and communication skills and ability to influence diverse

stakeholders and drive accountability and decision-making cross functionally.

▪ Ability to present data and defend approaches in front of management and

inspectors.

▪ Ability to partner with other functional group to achieve business objectives.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

Associate II, QC Technical

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

**SUMMARY**

The Associate II, QC Technical is responsible for owning and facilitating Quality Control laboratory investigation processes within the quality management system (Veeva QMS), with activities prioritized according to business needs and timelines. The primary focus of this position is to collaborate with QC supervisors, leads, and analysts to plan, coordinate, and advance investigations; identify probable contributing factors and/or root cause(s) for laboratory incidents; and facilitate the timely completion, review, approval, and closure of investigation records to support critical business objectives. The role manages a variety of record types, including laboratory investigations, deviations, calibration events, and environmental monitoring alert, action, and adverse trend evaluations.

**RESPONSIBILITIES**

• Facilitate and complete laboratory investigations (LIRs) for OOS, OOT, OOE, and system suitability/test acceptance failures, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need.

• Facilitate and complete deviation investigations related to QC laboratories and procedures, excursions, and adverse trends, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need.

• Serve as QC’s primary contact for documenting investigation findings and preparing trend or technical reports as necessary.

• Gather data, observe processes, and perform personnel interviews based on business priorities.

• Lead cross-functional root cause analysis using appropriate tools.

• Assign and prioritize child records based on risk, business need, and timelines.

• Align reviewers and SMEs on the investigation path and evolving priorities.

• Define appropriate CAPAs and effectiveness checks, providing ownership as needed.

• Identify trends and partner with appropriate teams for resolution.

• Define expected process impacts and monitor effectiveness with SMEs.

• Maintain QC investigations in compliance with company and regulatory standards.

• Partner with management and QA to prioritize and close QMS records within timelines aligned to business urgency as needed.

• Identify improvement opportunities and promptly escalate risks, barriers, or compliance concerns to appropriate management.

• Attend huddles as needed to provide investigation status updates and communicate support needs.

• Perform other assigned duties based on business needs and management direction.

**EXPERIENCE**

**Required Skills:**

• 6+ years’ experience working in a cGxP laboratory or related setting.

• Working knowledge of Root Cause Analysis (RCA) and Operational Excellence mechanisms.

• Knowledge with core chemistry principles and both microbiological and analytical methodologies such as purification, pH, bioburden, endotoxin, spectrophotometry, chromatography, ELISA, PCR, PAGE/CE, Activity and Enzyme Kinetics.

• High degree of accuracy and attention to detail.

• Strong written, particularly technical writing, and verbal communication skills.

• Strong time management, critical thinking, problem solving, decision making and leadership skills.

• Proficiency with QMS record and control document management software such as Veeva.

• Competence with usage of Microsoft Office Professional Suite (Word, Excel, PowerPoint, Outlook/Teams)

**Desired Skills:**

• Demonstrated fluency of cGMP / GLP principles and industry standards throughout 8+ years of direct QC/QA operation involvement.

• Ability to dynamically manage multiple and complex priorities to meet changing business needs.

• Detailed experience with performing RCA as well as determining how appropriate remediations can be to interface with requirements of current processes and regulatory requirements.

• Experience with FDA, EP and/or JP regulations with some extent of previous responsibilities pertaining to audit preparedness.

• Exposure or participation of real-time process and test method performance monitoring.

• Deployment of baseline statistical principles and applications such as control limits, variance, regression analysis, outlier detection, variable frameworks for performance comparability.

• Knowledge of utilizing Microsoft Power Platform to increase operational efficiencies.

• Demonstrated passion for continuous improvement and readily working within a team-oriented and collaborative environment.

**EDUCATION**

B.S./B.A. degree in relative science disciplines (major in biology – biochemistry – chemistry preferred).

**EQUIPMENT**

Vast majority of responsibilities will be served outside of a laboratory setting. A certain extent of interaction with QC lab operations will be required however is not expected to involve interfacing with specific pieces of instrumentation or equipment. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

**CONTACTS**

Job incumbent will interact with members of QC Leadership Team (QCLT), including direct manager of QC Technical, and Quality Contacts in QA to effectively prioritize and complete timely writeup and approval of robust investigations. Also to occur routinely is collaboration with team members, to seek guidance and alignment as well as mentor less experienced investigators. In addition, building cross-functional relationships with Manufacturing, QA Compliance, or QC ops at other company sites to convey and represent ongoing lessons learned and continuous improvement to systems or procedures will be expected on an as-needed basis.

**SUPERVISOR RESPONSIBILITY**

This position is not configured to have direct reports and no supervisor responsibilities apply.

**SHIFT DETAILS**

This position will principally operate during normal business hours from Monday – Friday, with some degree of flexibility required to collaborate with necessary teams to deliver effective and timely investigations.

**ONSITE, REMOTE, OR FLEXIBLE**

This is a flexible role requiring 2-3 days on-site on a weekly basis at the BPI Novato site. The on-site schedule may increase based on business priorities, operational needs, and team requirements.

**TRAVEL REQUIRED**

Travel is not anticipated to be required to facilitate routine responsibilities.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

AbbVie

Maintenance Technician III

Company Description

**About AbbVie**

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

Job Description

Independently perform Senior level support within the maintenance department. May help train Maintenance Tech I employees. This position utilizes the skills and knowledge to perform advanced or senior technician level tasks within their respective function and begins training into other maintenance functions as a multi-skilled technician.

Responsibilities

- • Adhere to Abbvie’s code of conduct
  • Maintains the function of department assets to ensure reliable equipment and quality standards are met.
- • Assists in root cause investigation and reliability centered maintenance analysis
  • Capable of training others on tasks.
  • Must begin to demonstrate proficiency in multiple skilled trade disciplines
- • Intermediate computer skills (MS Windows)
  • Fully proficient in their core function, performing advanced level tasks
  • Assist cross functional teams outside of the maintenance organization
- • Supports continuous improvement projects and safety initiatives within the maintenance organization and/or the site.
- • Understands and follows all safety and GMP regulations
  • Assist cross functional teams outside of the maintenance organization

Qualifications

- Knowledge and ability to use basic power tools and ability to apply proper hand and measuring tools in an industrial setting.
- YHS diploma with 5+ yrs. experience or Relevant Certificate with 3+ yrs. experience or Associates technical degree with 1+ yrs. experience.

Additional Information

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

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

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

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

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

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

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

Illinois

Data Scientist, Risk Based Quality Management Analytics

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

Risk Based Quality Management (RBQM) Analytics is an ambitious team of Data Scientists and Data Engineers with a unique blend of Business, Scientific, and Machine Learning expertise that seeks to unleash the full potential of AbbVie’s data assets by bringing technology and/or data and insights to the forefront of decision making via fit-for-purpose solutions. The Data Scientist role is a key role to enable application of advanced analytics techniques across clinical development continuum. Drives Analytics innovation and experimentation to enable data-driven insights for complex business problems across R&D by deploying advanced analytics techniques like Machine Learning and Visual Analytics.

Responsibilities

- For assigned projects, works with the cross-functional team to enable fit-for-purpose analytics solutions.
- Works with team to ensure analytical work product is consistent across projects where appropriate and that user experience is optimized and follows the design principles and standards established by the team
- Leverages proven statistical methodologies and those methodologies established as standard by the team; in addition to leveraging proven statistical methodologies and standards established by the team, experiments and recommends additional techniques to solve business problems
- Enables data-driven insights to support of assigned projects
- If assigned, participates in functional innovation and process improvement initiatives;
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
- Identify business needs and support the creation of standard KPIs, reports, and statistical analyses

Qualifications

- Bachelor’s degree statistics, analytics, bioinformatics, data science or equivalent field. Master’s degree preferred
- Must have 2-3 years of Data science and analytics-related experience
- Complete or Full / Career proficiency in R, Python, SQL, or other statistical packages. Intermediate-level knowledge of statistical and data mining techniques
- Intermediate proficiency with visualization tools like Spotfire, Tableau, Microstrategy or equivalent
- Experience with Machine Learning and other advanced analytics techniques preferred
- Demonstrated effective communication skills. Demonstrated ability to communicate analytical and technical concepts in layman’s terms
- Demonstrated problem-solving and analytical skills
- Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively

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>)

Maintenance Technician I - Maintenance

**About the Department**

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

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

What we offer you:

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

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

**The Position**

Improve systems & equipment reliability in assigned process area, reduce system/equipment downtime associated with assigned process & support operation of assigned process.

**Relationships**

Reports to Manager/Supervisor Technical Support.

**Essential Functions**

- Work in a safe & environmentally responsible way
- Actively improve performance & reliability of process equipment
- Restore function to equipment in an effective & technically correct manner
- Actively lead Event Response
- Plan & Perform corrective & preventative maintenance on assigned process
- Monitor performance & trends & provides action plans for assigned process(s)
- Support & implement system/equipment reliability improvement projects
- Support & assist in training & coaching of process operations
- Record & review maintenance & repair data in BPR’s & associated forms
- Review & coach the use of SAP to include Work Order oversight & completion
- 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. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require color 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 environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid drivers license.

**Qualifications**

- Education: Associate’s Degree in relevant field, or equivalent military training or industrial training (which includes a thorough understanding of mechanical, electrical & control systems) required
- Minimum of three (3) years of relevant work experience required
- Knowledgeable in the following systems: Compressed Air, Electro-Mechanical controls, Electrical, Mechanical, Instrumentation & robotics preferred
- Ability & experience with automated records systems such as SAP, schematics, wiring diagrams & other technical documents preferred
- Computer literacy preferred
- Knowledge & application experience of various troubleshooting strategies preferred
- Organization/Planning: Support planning & execution of process functions & lead coordination of planned & corrective maintenance activities to ensure successful process performance 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.

Industrial Utilities Maintenance Technician II (NIGHTS)

**About the Department**

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

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

What we offer you:

• Leading pay and annual performance bonus for all positions

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

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

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

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

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• Employee Referral Awards

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

**The Position**

Support & improve all facility maintenance efforts including preventive/predictive maintenance efforts, repairs, troubleshooting, & new equipment installation. Support & participate in plant Shutdown activities for Facilities & Utility equipment. Coach & participate in A3/3C problem solving. Support training for junior team members.

**Relationships**

Reports to Manager/ Supervisor.

**Essential Functions**

- Support consistent operation, maintenance & response for all plantwide refrigeration systems
- Perform corrective & preventative maintenance on assigned process in a timely manner
- Manage individual training plan
- Ensure that all Maintenance activities are documented in SAP & communicated in the shift turnover reports
- Partner with process owners to actively improve performance & reliability of process equipment
- Perform routine cleaning and maintain good housekeeping for assigned areas
- Execute site rounds and equipment inspections of all Utilities independently to ensure efficient and compliant operations
- Drive continuous process improvement using cLEAN® concepts
- Support the development & establishment of maintenance procedures, maintenance plans & spare parts lists for processes assigned
- Support the maintenance team's development by instructing other technicians in specialized areas and acquiring knowledge about new systems
- Ability to work rotating shifts, night shifts, extended shifts &/or weekends
- Lead teams in Systematic Problem Solving (SPS) tools to establish Root Cause Analysis & resolve equipment issues
- Participate in plant Shutdown planning & execution
- Ability to interpret mechanical & electrical specifications, drawings & other technical data sheets.to support project site
- Support the installation, commissioning, qualification & training activities for all Site Utilities systems & controls
- Support consistent operation, maintenance & response for all plantwide refrigeration systems
- Follow all safety & environmental requirements in the performance of duties
- Other duties, 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. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 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 gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Qualifications**

- Associate's degree in a relevant field of study from an accredited university required
- Minimum four (4) years of experience and knowledge in mechanical, electrical and/or control systems required
- May consider a High School Diploma/GED with a minimum of six (6) years of experience and knowledge of mechanical, electrical and/or control systems required
- Ability to lead & guide fellow technicians with daily tasks & activities preferred
- Experience with automated records systems such as SAP/CMMS preferred
- Proficiency in reading schematics, wiring diagrams & other technical documents required
- Computer literacy required
- Experience in planning/organizing work, checking results & revising the work plan in accordance with the daily work plan required
- Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts preferred, to include active participation in driven event response activities and document problems & work to ensuring rapid resolution & prevent recurrence required
- Technician:
  - Ability to work with electronic batch records, automated process equipment and/or BMS and FMS systems required
  - Knowledgeable of Compressed air, Plant steam, Vacuum, Chilled Water, RO/ Pretreatment water systems required
  - Knowledgeable of WFI water systems, Clean Steam Systems preferred
  - Proficient in the operation and design production utility systems such as: purified water, process air, chemical storage, process waste systems, chilled water, clean and dirty steam, high pressure air, vacuum, air handling equipment required
  - Proficiency in Refrigeration and HVAC types with emphasis on Ammonia refrigeration 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.