Quality

Regeneron Pharmaceuticals, Inc.

Supervisor Quality Control

Regeneron is looking for a 2nd shift Supervisor Quality Control. This role will be responsible for supporting the laboratory with testing and/or data review on release drug products, stability samples and non-routing samples in support of the companys quality program. This position will also be responsible for providing on the floor support to the analyst. This position will have direct reports.

**When & Where:**

- 2nd Shift, Sunday - Thursday 12PM - 8:30PM
- Location: Rensselaer, New York, United States

**Discover your role:**

- Supervise QC staff, assign and balance workload, and monitor progress against deadlines and priorities

- Generate test results as well as review test results to ensure compliance with standards; reports any quality anomalies.

- Calibrate and maintain laboratory equipment; participate in equipment qualifications.

- Perform a review of testing performed within the laboratory to ensure compliance with standards.

- Provides on-the-floor guidance and support to employees during routine testing.

- Provide employees with support on laboratory investigations and participate in owning investigations.

- Write, revise, and review controlled standard operating procedures.

- Responsible for leading a cross functional project.

- Completes, reviews, and reconciles logbooks to ensure compliance with cGMP standards and internal procedures.

- Reviews and approve laboratory maintenance records to support daily laboratory operations.

- Reviews and approve employees timesheets by end of the week.

- Delivers training to employees and ensure requirements are met. Maintain up to date training records for self and direct reports.

- Perform minimally monthly performance feedback meetings with direct reports.

- Escalates all performance issues to management and/or HR.

**This role requires:**

- BS/BA in Chemistry, Biochemistry or related field required; MS preferred

- 5+ years of progressive, relevant QC experience, preferably within the pharmaceutical or biotechnology industry

- Prior supervisory or leadership experience required

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)**

$78,700.00 - $128,700.00

New York

Senior Manager, Global Development Quality Lead Japan

**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 Senior Manager, Global Development Quality Lead Japan, to join our Global Development Quality & Regulatory Compliance team, supporting our Japan affiliate in a hybrid work model. In this role, you will drive quality and compliance in local operations by providing expert guidance and leadership for the Regeneron quality management system supporting GCP, GVP, Medical and Regulatory Affairs. You will collaborate with cross-functional teams and key stakeholders across local and global functions. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Japan

Work model: Hybrid

**Discover your role:**

- Lead quality and compliance activities for GCP, GVP, Medical and Regulatory Affairs at the Japan affiliate.
- Build strategic partnerships and drive proactive, risk-based quality initiatives, including audits, with key stakeholders.
- Optimize inspection readiness and support inspection preparation for local affiliate operations.
- Contribute to process improvement initiatives and lead projects aligned with quality objectives.
- Manage issue resolution and escalate serious non-compliances through established processes.
- Provide expert guidance, training, and support on international regulations and Regeneron standards.
- Line manage, coach, and mentor junior team members or serve as process owner, as assigned.
- You exemplify a quality mindset, professional conduct, and continuous learning in all interactions.

**This role requires:**

- Bachelors degree (or equivalent experience) and at least 8 years of relevant healthcare/pharmaceutical industry experience.
- Advanced knowledge and application of GCP guidelines, including managing complex quality and compliance issues.
- Experience in quality/compliance or clinical development roles, with expertise in GCP.
- Proven ability in training, supervising, line management, and staff development.
- Strong project management, planning, prioritization, and time management skills.
- Advanced digital literacy, including Microsoft Office suite.
- Effective communication and stakeholder engagement skills, with ability to influence senior leaders.
- Demonstrated ability to manage multiple priorities with urgency and attention to detail.
- Understanding of risk-based quality management and process improvement.
- Business level fluency in Japanese and English language
- Behavioral strengths including integrity, adaptability, critical thinking, and collaborative problem solving.

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

Temp QA Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Temp QA Specialist** to join our **QA Raw Materials** 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

**What youll do:**

- Providing QA oversight and support for manufacturing operations, serving as the primary quality representative within production areas
- Partnering with cross-functional teams to facilitate issue resolution, including troubleshooting equipment, process, and schedule disruptions, while ensuring appropriate documentation and quality oversight
- Assessing and triaging potential non-conformances in real time, ensuring required information and documentation are secured to support investigations
- Reviewing and approving documentation associated with routine and non-routine manufacturing activities, including area clearances, incursions, changeovers, and other operational events
- Participating in shift meetings and operational discussions, providing quality mentorship, observations, and recommendations related to ongoing activities and containment actions
- Providing quality consultation and guidance in alignment with QA policies, procedures, and regulatory expectations
- Representing Quality Assurance in the management of complex deviations, change controls, CAPAs, and other quality systems, including active participation in investigations, root cause analysis, and corrective action implementation
- Supporting employee development through training, coaching, and mentoring on QA processes, procedures, and standards
- Performing activities related to product disposition and release, including review of manufacturing records and supporting documentation
- Reviewing and approving investigations associated with product, process, and manufacturing events
- Identifying opportunities for continuous improvement and support initiatives that improve product quality, compliance, and operational efficiency

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

- Excellent organisational skills and attention to detail
- You have the ability to learn and utilise computerised systems for daily performance of tasks
- Strong written, verbal and interpersonal communication skills and can optimally interact cross functionally
- You have the ability to prioritise, manage multiple tasks, and meet deadlines

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

- **Assoc Specialist** - BS/BA in scientific discipline or related field or equivalent combination of education and experience
- **Specialist** - BS/BA in scientific discipline or related field with min 3 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
- **Sr Specialist** - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience

Thrive today. Grow tomorrow.

\#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA #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.

Associate Director Precision Medicine - Clinical Diagnostics

**Build our future together:**

We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns companion diagnostic programs from early biomarker feasibility through clinical validation, regulatory submission, and launch translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.

**When & where:**

- Location: Remote, USA

**Discover your role:**

- Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles, defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
- Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
- Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

**This role requires:**

- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
- 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
- Track record translating biomarker science into validated assays supporting drug approvals.
- Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
- Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

\#PrecisionMedicineCDX

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)**

$176,100.00 - $287,300.00

Nationwide

QC Microbiology Scientist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **QC Microbiology Associate Scientist / Scientist** to join our **QC Tech Resources** team.

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

**Where:**

- Location: Raheen, Limerick

**What youll do:**

- Validating methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.
- Writing technical documentation, including position papers, validation reports, and microbiological investigations.
- Culturing organisms, conducting research, and characterizing them for use in investigations and cleaning development.
- Reviewing new test procedures and assays for accuracy and compliance.
- Evaluating and acquiring new methodologies, techniques, and equipment as needed.
- Overseeing contract laboratory testing to ensure quality and compliance.
- Setting product specifications and alert/action levels for microbiological standards.
- Leading technical troubleshooting and problem investigations.
- Reviewing assay, process, and equipment validation reports, as well as other technical documents for correctness and regulatory compliance.
- Coaching junior team members on good microbiology lab practices and modern aseptic techniques.
- Supporting and participating in regulatory inspections to ensure compliance.
- Demonstrating investigational skills and working knowledge of microbiology assay development and validation.

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

- You have a proven record to work independently or as part of a team.
- Possessing a strong background in pharmaceutical microbiology, GMP working experience in QC labs, and aseptic techniques.
- You possess strong trouble-shooting and problem solving skills.
- You have strong attention to detail & excellent written and oral skills.

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

- Assoc QC Microbiology Scientist: Minimum 0-2 years of Experience
- QC Microbiology Scientist: Minimum 2 years of Experience
- To be considered for this opportunity you should have a BS/BA or equivalent experience in Microbiology or related field and 2+ years of validated experience, or equivalent combination of education and experience.

**Thrive today. Grow tomorrow.**

**#IRELIM #JOBSIEST #LI-Onsite #REGNIEQC**

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)**

37,000.00 - 88,400.00

2027 Co-op QC Analytical & Bioassay Sciences (IOPS)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking multiple 2027 Co-ops in QC Analytical & Bioassay Sciences (IOPS) to join Regeneron Industrial Operations and Product Supply (IOPS) **Quality Control (QC) Analytical Sciences** team which tests the identity, strength, purity, potency, and stability of Regeneron's commercial products.

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, NY (Temple Lane / Tech Valley)

**Timeframe:** Our Co-op positions are full-time and onsite from January-August (Spring-Summer), May/June-December (Summer-Fall), and August-December (Fall).

*This role typically runs from January through August, January through May, or May through December.*

**Pay**: Intern and Co-op pay ranges are determined by level of education (year in school) and degree program. The hourly rate range for these locations is: $17.90-$25.50 per hour.

**What youll do:**

- Support analytical method development and validation for monoclonal antibody, cell therapy, and gene therapy quality control

- Perform chromatography, mass spectrometry, quantitative polymerase chain reaction (qPCR), enzyme-linked immunosorbent assay (ELISA), and droplet digital PCR (ddPCR) techniques

- Contribute to assay automation and new-technology onboarding, including next-generation sequencing (NGS)-based assays and liquid-handling robotics

- Support cell banking process scale-up activities

- Contribute to potency assay development for cell and gene therapy products

- Perform statistical analysis supporting method comparability studies

- Develop automated methods comparable to existing manual methods

- Document experimental procedures and results

**Relevant majors:** Chemistry, Biochemistry, Biology, Analytical Chemistry, Biotechnology, Computer Science (for automation-focused projects)

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

- Must be enrolled in, or accepted to, an academic program pursuing an Undergraduate or Graduate degree (and be returning to school the semester following the position or graduating after the position)

- Must be able to commit to 40 hours per week from January-August, May/June-December, or August-December

- Demonstrated leadership in areas such as campus activities, clubs, sports, current or previous work, or within the community preferred

- Cumulative GPA of 3.0 or higher 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.

Associate Director, Precision Medicine (Clinical Diagnostics)

**Build our future together:**

We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external In Vitro Diagnostic (IVD) partners to ensure diagnostics keep pace with therapeutic milestones.

**When & where:**

- Location: Dublin, Ireland (multiple locations are being considered for this role.)
- Work model/flexibility: 3 days onsite

**Discover your role:**

- Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
- Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
- Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

**This role requires:**

- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
- 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
- Track record translating biomarker science into validated assays supporting drug approvals.
- Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
- Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

\#PrecisionMedicineCDX

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)**

101,500.00 - 165,200.00

Senior Manager Quality Assurance, Medical Device (Sustaining)

**Build our future together:**

Regeneron is currently seeking a Senior Manager, Medical Device Quality Assurance (QA) to join our Medical Device QA team. This expanded leadership role will provide QA oversight across two critical functions: Combination Products Sustaining Engineering and Compliance. The position will lead a team of engineers and quality specialists.

**When & where:**

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

**Discover your role:**

- Manage, mentor, and develop quality engineering and compliance teams
- Standardize, streamline, and improve processes across sustaining and compliance
- Implement digital, data-driven tools for accurate, consistent, and timely reporting
- Lead teams through complex, ambiguous challenges in a pharmaceutical/medical device environment
- Sustaining Engineering Support:
  - Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management File
  - Advice and actively participate in Design Reviews associated with combination products
  - Provide QA and technical support to quality engineers and project teams during ongoing maintenance of the combination product
  - Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities

- Combination Product Support:
  - Act as Management Representative for the combination products QMS; own policies and procedures
  - Support regulatory inspections and partner audits for combination products
  - Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates

**This role requires:**

- BS in Engineering and 8+ years of experience; including combination product or medical device experience; or equivalent combination of education & experience
- Previous supervisory/ people leadership experience
- Knowledge of the combination device development and lifecycle process

\#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)**

$126,300.00 - $206,100.00

Principal Quality Assurance Validation Specialist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Assurance (QA) Validation Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position validates and qualifies laboratory and analytical equipment in accordance with regulatory requirements, with secondary support for manufacturing equipment and utility validation in a highly automated, digitally integrated biologics environment. This role may have direct reports in the future.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
  - Other requirements: Occasional flexibility may be requested for on-call schedule/weekend work

**Discover your role**:

- Generates, executes, and/or reviews master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment (e.g., HPLC, GC, balances, spectrophotometers, incubators) for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
- Investigates and troubleshoots problems which occur with laboratory equipment and determines solutions or recommendations for changes and/or improvements
- Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
- Reviews, edits, and approves change controls, SOPs, reports, and other documentation
- Provides secondary support for qualification of manufacturing equipment and utilities as needed
- Coordinates with Quality Control, Manufacturing Science, and outside contractors/vendors, including Automation and Computer Systems Assurance, to complete validation tasks for a highly automated facility
- Trains, advises and mentors teammate as needed
- May manage full-time employees as well as contractors
- Manages projects and prepares status reports
- Other duties assigned by management

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

- Gowning: Full cleanroom attire (examples may include 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

**This role requires:**

- BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
  - Principal QA Validation Specialist: 8+ years of relevant experience
  - Staff QA Validation Specialist: 10+ years of relevant experience
  - Level will be determined based on experience

- Previous people leadership/supervisory experience preferred

- Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is 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)**

$92,200.00 - $176,000.00

Quality Assurance Validation Specialist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Assurance (QA) Validation Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position validates and qualifies laboratory and analytical equipment in accordance with regulatory requirements, with secondary support for manufacturing equipment and utility validation in a highly automated, digitally integrated biologics environment.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
  - Other requirements: Occasional flexibility may be requested for on-call schedule/weekend work

**Discover your role**:

- Generates, executes, and/or reviews master and completed qualification and validation protocols, summary reports, and associated data for laboratory and analytical equipment (e.g., HPLC, GC, balances, spectrophotometers, incubators) for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
- Investigates and troubleshoots problems which occur with laboratory equipment and determines solutions or recommendations for changes and/or improvements
- Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions
- Reviews, edits, and approves change controls, SOPs, reports, and other documentation
- Provides secondary support for qualification of manufacturing equipment and utilities as needed
- Coordinates with Quality Control, Manufacturing Science, and outside contractors/vendors, including Automation and Computer Systems Assurance, to complete validation tasks for a highly automated facility
- Trains, advises and mentors teammate as needed
- May be required to oversee contingent workers
- Manages projects and prepares status reports
- Other duties assigned by management

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

- Gowning: Full cleanroom attire (examples may include 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

**This role requires:**

- BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
  - Associate QA Validation Specialist: 0-2+ years of relevant experience
  - QA Validation Specialist: 4+ years of relevant experience
  - Sr. QA Validation Specialist: 6+ years of relevant experience
  - Level will be determined based on experience
- Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is 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)**

$62,355.00 - $128,700.00

QA Specialist, Internal Bulk Batch Review

**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 to support our Internal Bulk Batch Review activities within Manufacturing. In this role, the Quality Assurance Specialist Performs activities in support of dispositioning products while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. 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, 12:00 PM - 8:30 PM

**Discover your role:**

- Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Review of completed batch records and collaborating with other departments to resolve issues, communicating internally (Tarrytown, Raheen, Temple) and externally effectively
- Provide consultation or advice in alignment with QA policies
- Train and/or mentor junior employees, including providing insights and education on processes and procedures;
- Perform activities associated with disposition of products (e.g. document review, shipping, etc.). Activities may be on the production floor or at a desk.
- Review, edit, or approve Regeneron controlled documents
- Perform status labeling of product
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

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

- Have an understanding of biologics manufacturing operations
- Excel in a quality driven organization
- Are organized and have an attention to detail.
- Have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Can manage multiple assignments and changing priorities.
- Can learn and utilize computerized systems for daily performance of tasks
- Ability to prioritize, manage multiple tasks, and meet deadlines

**This role requires:**

Requires BS/BA in scientific discipline or related field and minimum. May substitute proven experience for education requirement.

- Assoc QA Specialist: minimum of 2 years relevant experience.
- Specialist: minimum of 4 years relevant experience.
- Sr Specialist: minimum 6 years relevant experience.

Level is determined based on qualifications relevant to the role.

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

Manager Quality Assurance Validation

**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 Assurance (QA) Validation to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the laboratory and analytical equipment validation function. They are responsible for qualification of laboratory and analytical instrumentation supporting quality control (QC) and manufacturing science functions, with secondary oversight of manufacturing equipment, utility qualification, and cleaning/sterilization validation processes. They will participate in and defend validation data during FDA and other regulatory inspections.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
  - Other requirements: Occasional flexibility may be requested for on-call schedule/weekend work

**Discover your role:**

- Designs and develops policies related to laboratory and analytical equipment qualification and validation, and secondarily to manufacturing equipment, utility, and process validation, ensuring effective administration and regulatory compliance
- Responsible for all aspects of QA laboratory equipment validation, including review and approval of failure investigations, change controls and associated test plan documentation, SOPs, qualification protocols and summary reports, and relevant Validation Master Plan content
- Leads qualification strategy for laboratory and analytical instrumentation (e.g., HPLC, GC, spectrophotometers, balances, incubators, and software-integrated analytical systems) supporting QC, manufacturing science, and release testing
- Provides secondary oversight of manufacturing equipment and utility qualification and cleaning/sterilization validation programs
- Develops and manages validation budget, contracts, and schedules
- Presents and defends validation data to FDA and other regulatory agencies
- Maintains the validation document and software control system for laboratory equipment and instrumentation qualification records
- Ensures validated state is maintained for laboratory, analytical, and manufacturing equipment used in commercial and clinical operations
- Organizes QA Validation resources assigned to functional areas to meet goals and timelines; coordinates prioritization of activities with laboratory and manufacturing area management
- Partners with the Director, QA Validation & Computer Systems Assurance, and with Quality Control/Manufacturing Science leadership to align laboratory equipment qualification strategy with the site's CSA and automation qualification programs
- Plays a proactive role in developing and applying new approaches and processes to laboratory and equipment validation strategies for a highly automated facility
- Counsels employees on work performance; conducts hiring and separation activities

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

- Gowning: 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
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**This role requires:**

- BS/BA in Engineering, Chemistry, Life Sciences or a related field; or equivalent combination of education and experience
  - Associate Manager QA Validation: 6+ years of experience
  - Manager QA Validation 7+ years of experience
  - Level will be determined based on experience
- Previous people leadership/ supervisory experience
- Experience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP QC or manufacturing science environment
- Experience validating equipment and utilities in a highly automated or greenfield manufacturing environment is 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)**

$92,200.00 - $176,000.00

Sr. QA Specialist, Internal Bulk Batch Review

**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 Sr. Quality Assurance Specialist to support our Internal Bulk Batch Review activities within Manufacturing. In this role, the Quality Assurance Specialist performs activities in support of dispositioning products while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. 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, 12:00 PM - 8:30 PM

**Discover your role:**

- Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Review of completed batch records and collaborating with other departments to resolve issues, communicating internally (Tarrytown, Raheen, Temple) and externally effectively
- Provide consultation or advice in alignment with QA policies
- Train and/or mentor junior employees, including providing insights and education on processes and procedures;
- Perform activities associated with disposition of products (e.g. document review, shipping, etc.). Activities may be on the production floor or at a desk.
- Review, edit, or approve Regeneron controlled documents
- Perform status labeling of product
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

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

- Have an understanding of biologics manufacturing operations
- Excel in a quality driven organization
- Are organized and have an attention to detail.
- Have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Can manage multiple assignments and changing priorities.
- Can learn and utilize computerized systems for daily performance of tasks
- Ability to prioritize, manage multiple tasks, and meet deadlines

**This role requires:**

Requires BS/BA in scientific discipline or related field. May substitute proven experience for education requirement.

- Assoc QA Specialist: minimum of 2 years relevant experience.
- Specialist: minimum of 4 years relevant experience.
- Sr Specialist: minimum 6 years relevant experience.

Level is determined based on qualifications relevant to the role.

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 - $150,600.00

Senior Manager, Precision Medicine - Clinical Diagnostics

**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 Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics (CDx) strategy and execution across our therapeutic indications. In this role, you will translate scientific needs into fit-for-purpose assays for global decisions, owning programs from feasibility through validation, registration, launch, and post-market sustainment, while partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators.

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

**When & where:**

- Location: Remote, USA

**Discover your role:**

- Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines
- Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership
- Manage IVD partners, negotiating scope, timelines, budgets, and quality, and overseeing co-development and Joint Steering Committees
- Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), driving analytical and clinical validation
- Embed CDx assays in trials with clinical teams, covering screening/stratification, sampling, site readiness, and lab operations
- Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses
- Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness
- Thrive in a fast-paced, multi-tasking environment, bringing strong communication skills to cross-functional collaboration.

**This role requires:**

- PhD in molecular biology, pathology, biomedical engineering, or equivalent
- 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations
- Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions
- Expertise in NGS, PCR, IHC, and immunoassays, along with validation standards and quality systems
- Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling
- Excellent communication, leadership, and stakeholder management skills, with the ability to deliver clear updates to executive audiences

\#PrecisionMedicineCDX

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)**

$150,500.00 - $245,500.00

Quality Control Analyst

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring multiple Quality Control (QC) Analysts to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. The QC Analyst performs a variety of chemical/biological/microbial analyses or sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples in support of the companys quality program.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model:
  - Initial: full time, on-site 1st, Mon-Fri, 8am-4:30pm
  - Permanent: full time, on-site, rotating 12-hour shifts, 7am-7:30pm , 34 days per week, includes 1 weekend day
  - Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.

**What you'll do:**

- Gather data and documents test results
- Review test results to ensure compliance with standards; reports any quality anomalies
- Comply with all pertinent regulatory agency requirements
- Participate in required GMP training activities
- Maintain laboratory supplies
- Conduct testing and sampling on raw materials, in-process, product, stability, and/or research samples
- Write and revise control test procedures and standard operating procedures (SOPs)
- Complete test records and reviews data
- Calibrate or verify calibration of instruments/devices prior to use
- Interact with outside customers or functional peer groups
- Engage in exciting projects aligning to our scientific initiatives
- Devise or develop new analytical methods and techniques
- Assist in validation of methods
- Partner with internal teams on establishing the transfer of methodology from R&D

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

- Gowning: Full cleanroom attire (examples may include: 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
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**Let's find out if we're a fit:**

- Requires B.S in Life Sciences or related field; or equivalent combination of education and experience
  - Associate Quality Control Analyst: 0-2 years of experience
  - Quality Control Analyst: 2+ years of experience
  - Senior Quality Control Analyst I: 4+ 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 (hourly)**

$24.76 - $44.42

Quality Control Analyst (Overnights)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring multiple Quality Control (QC) Analysts to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. The QC Analyst performs a variety of chemical/biological/microbial analyses or sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples in support of the companys quality program.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States
- Work model:
  - Initial: full time, on-site 1st, Mon-Fri, 8am-4:30pm
  - Permanent: full time, on-site, rotating 12-hour shifts, 7pm-7:30am , 34 days per week, includes 1 weekend day
  - Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.

**What you'll do:**

- Gather data and documents test results
- Review test results to ensure compliance with standards; reports any quality anomalies
- Comply with all pertinent regulatory agency requirements
- Participate in required GMP training activities
- Maintain laboratory supplies
- Conduct testing and sampling on raw materials, in-process, product, stability, and/or research samples
- Write and revise control test procedures and standard operating procedures (SOPs)
- Complete test records and reviews data
- Calibrate or verify calibration of instruments/devices prior to use
- Interact with outside customers or functional peer groups
- Engage in exciting projects aligning to our scientific initiatives
- Devise or develop new analytical methods and techniques
- Assist in validation of methods
- Partner with internal teams on establishing the transfer of methodology from R&D

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

- Gowning: Full cleanroom attire (examples may include: 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
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**Let's find out if we're a fit:**

- Requires B.S in Life Sciences or related field; or equivalent combination of education and experience
  - Associate Quality Control Analyst: 0-2 years of experience
  - Quality Control Analyst: 2+ years of experience
  - Senior Quality Control Analyst I: 4+ 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 (hourly)**

$24.76 - $44.42

CMC Product Quality Compliance Specialist (PQR)

**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 **CMC** **Product Quality Compliance Specialist** to support our Product Quality Review (PQR) activities. In this role, you will be responsible for being a quality representative for product and distribution compliance of Regenerons commercial programs including support with the product quality reviews (PQR). This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and overseeing product management activities. Works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

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, 8:00 AM - 4:30 PM

**Discover your role:**

- Oversees the global change management implementation plan
- Supports the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
- Oversees the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
- Assesses quality-related information to detect trends and works with subject matter experts to determine the need for actions required in response to those trends
- Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
- Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
- Collaborates cross-functionally to support regulatory release process and inventory review.
- Execute relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
- Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
- Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities, and launch material is aligned with the applicable regulatory dossiers.
- Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, PDR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
- Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.

**This role requires:**

Requires BS/BA in Chemistry, Biology or related field.

- Assoc QA Specialist: minimum of 0- 2 years relevant experience. with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience

- Specialist: minimum of 2 years relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

- Sr Specialist: minimum 5 years relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

Level is determined based on qualifications relevant to the role.

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

Manager Facilities Maintenance

**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, Facilities Maintenance to join our Technical Operations team at our new highly automated drug substance manufacturing site in Saratoga Springs. This role is primarily responsible for the direction, organization and supervision of all facilitys general operations and functions including calibration & process maintenance teams.

**When & where:**

- Location:
  - Initial: Rensselaer, New York, United States
  - Permanent: Saratoga Springs, New York, United States

- Work model:
  - Initial: full-time, on-site 1st, Mon-Fri, 8am-4:30pm
  - Permanent: full time, on-site, rotating 12-hour shifts, 7am-7:30pm, 34 days per week, includes 1 weekend day
  - Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.
- Travel: 10% domestic

**Discover your role:**

- Lead the supervision, planning, and scheduling of maintenance, repairs, and modifications for systems and equipment, ensuring safety, and quality
- Oversee and administer contract maintenance personnel performing repairs and modernization activities, ensuring contractor qualification, scope alignment, and compliance with regulatory and local requirements
- Identify, evaluate, and implement program and process improvements that enhance safety, quality, efficiency, and cost-effectiveness
- Manage and prioritize work requests, ensuring timely completion across IOPS Rensselaer satellite locations and consistent communication with stakeholders
- Contribute to departmental and cross-functional projects and initiatives by providing subject-matter expertise, coordination, and execution support
- Ensure compliance with applicable GxP/GMP/GLP requirements; maintain inspection readiness and support internal, partner, and regulatory audits
- Maintain and update-controlled documentation with proper version control, accuracy, and alignment to quality system requirements
- Support event and deviation investigations and drive or facilitate corrective and preventive actions (CAPA) within the quality system to prevent recurrence
- Perform other related duties as assigned to support departmental objectives and organizational priorities

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

- Gowning: Full cleanroom attire (examples may include 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
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**This role requires:**

- BS in Engineering, or a related field; or equivalent combination of education and experience
  - Assoc Manager Facilities Maintenance: 6+ years of experience
  - Manager Facilities Maintenance: 7+ years of experience
  - Level will be determined based on experience
- Previous people leadership/ supervisory experience

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

Quality Control Data Reviewer

Regeneron is looking for a QC Data Reviewer to perform data review to support release, stability programs, and lab operation within Quality Control. This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. This position is a **Tuesday Saturday 8am-4:30pm schedule.**

As the QC Data Reviewer, a typical day might include the following:

Executing detailed data review for analytical test results generated by QC for compliance with cGMP, internal SOPs and Specifications

Supporting production, stability studies, and lab operations

Reviewing release and stability data, trend charts of reference standards, lab equipment calibration records and logbooks

Performing detailed data review for analytical test results created by contract testing labs to assure correctness and accuracy

Maintaining and updating relevant SOPs for data review and reporting

Collaborating with Stability and other groups to support stability report writing and regulatory updates

Participating in all vital training activities

This role might be for you if:

- You have a solid understanding of data reviewing and regulatory agency guidelines
- You are results-oriented and can optimally analyze data trends
- You can work efficiently as an individual as well as with others
- You are a strong communicator who is willing to build beneficial relationships with other peer groups

To be considered for this role, you must have a BS/BA in Chemistry, Biology, or related field. You must be willing and able to work Tuesday Saturday 8am-4:30pm. Level will be determined by demonstrated experience.

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)**

$24.76 - $38.70

Project Specialist Quality Control

We are currently looking to fill a Project Specialist on our Quality Control Technical Resources Team. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing. Regeneron has successfully commercialized numerous products and in this fast-paced environment with a strong pipeline, QC Technical Resources Specialists have the opportunity to develop scientifically and also gain insight into other areas of the business.

**When & Where:**

- MondayFriday, 8:00am4:30pm
- Location: Rensselaer, New York, United States

**Discover your role:**

- Project manage validation and qualification activities within the QC TR Chemistry group
- Collaborate with internal and external teams to coordinate project management activities
- Write and revise assay transfer protocols to external partners and contract labs
- Write and revise control test procedures and SOPs
- Coordinate and participate in weekly project update meetings
- Communicate to management any delay in validation/transfer timelines
- Communicate method updates to partners and manage progress of updates
- Coordinate post-transfer investigations between contract sites and collaborative partners
- Raise discrepancies to management, as needed
- Multi-task, prioritize and execute projects independently
- Write and review transfer documents such as protocols and reports
- Communicate cross-functionally to business units
- Develop and drive scientific and/or business-related improvement ideas
- Possess effective time management skills, and the drive to meet deadlines
- Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

**This role requires:**

A BS/BA in Chemistry, Biochemistry, Biology or related field, with 3+ years of relevant experience.

Experience with project management and experience in a GMP setting.

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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