Temporary-Quality Reviewer / Batch Release Specialist
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...
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