Temporary-Quality Reviewer / Batch Release Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; Híbrido; USD 65.000 - 95.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Quality Reviewer / Batch Release Specialist to verify CoAs and batch records, ensuring release in line with approved specs and regulatory filings.

The role collaborates with regulatory leads and global teams to safeguard quality across clinical and commercial products. Candidates should have a life sciences degree and 2+ years' QA/QC/CMC experience, with GMP knowledge and familiarity with regulatory structures.

Formación

• Bachelor's degree in life sciences, chemistry, pharmacy, or related field.
• 2+ years' experience in pharmaceutical/biotech QA, QC, regulatory affairs, or CMC operations.

Responsabilidades

• Review batch status forms and CoAs to confirm lot disposition and shelf life.
• Cross-check release panels, acceptance criteria, and CoA against specifications and regulatory filings.
• Verify manufacturing/testing site information aligns with regulatory dossiers.
• Identify and document discrepancies between CoA data and filings; assess impact on release.
• Submit endorsement/release forms and maintain record versions for future reviews.
• Ensure compliance with SOPs, work instructions, and cGMP requirements.
• Support QP certification processes and country-specific release requirements.

Conocimientos

Quality assurance

Batch release

Regulatory compliance

Educación

Bachelor's degree in life sciences, chemistry, pharmacy, or related field

Herramientas

Veeva

LIMS

Descripción del empleo

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 Reviewer / Batch Release Specialist supporting clinical and commercial lot release across our global product portfolio. In this role, you will safeguard product quality and regulatory compliance by verifying batch records and Certificates of Analysis against approved specifications, while collaborating with regulatory leads, global regulatory teams, and distribution compliance. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: US
• Work model/flexibility: Remote or on-site in Rensselaer, NY (5 days/week)
• Contract duration: 6 months

Discover your role:

• Review batch status forms and CoAs for drug substance, formulated drug substance (and drug product (labeled and unlabeled) to confirm lot disposition (released/quarantined), manufacturer/site, and shelf life/expiry
• Cross-check release testing panels, acceptance criteria, and release results in the CoA against approved specifications (e.g., P.5.1, S.4.1) and current regulatory filings (IMPD, IND, CTA, BLA, MAA)
• Verify manufacturing/testing site information, container closure, formulation, and dosage form align with the applicable regulatory dossier
• Identify and document discrepancies between CoA data and regulatory filings; assess whether discrepancies prevent lot release/endorsement
• Call out blocking discrepancies to appropriate collaborators (e.g., regulatory representatives, global regulatory leads, distribution compliance) for resolution or filing amendment
• Complete and submit required endorsement/release forms in the relevant quality system (e.g., Veeva, LIMS, or equivalent)
• Maintain accurate records of specification versions, filing versions, and prior review outcomes to support efficient future reviews
• Ensure activities follow applicable SOPs, work instructions, and cGMP requirements
• Support QP certification processes (EU/UK) and country-specific release requirements

This role requires:

• A Bachelor's degree in life sciences, chemistry, pharmacy, or related field (advanced degree a plus) and 2+ years' experience in pharmaceutical/biotech Quality Assurance, Quality Control, Regulatory Affairs, or CMC operations.
• Working knowledge of GMP, batch record review, and lot release/disposition processes
• Familiarity with regulatory filing structures (CTD Module 3, IMPD, IND, BLA/MAA)
• Experience with clinical trial or commercial lot release preferred
• Familiarity with QP certification processes and global distribution compliance preferred

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/. For other locations, additional information will be provided during the recruitment process.

Many roles are required to be performed on‑site.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.