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Regulatory Compliance Specialist
2 months ago
Job Summary
We are seeking a highly skilled and experienced Senior Quality Control Specialist to join our Quality Control team at Regeneron Pharmaceuticals, Inc. as a part of our new Regeneron Cell Medicines group.
Key Responsibilities
- Oversee contract lab testing and support safety testing for novel drug products targeting oncological indications.
- Provide oversight for the testing of release, stability, and routine environmental monitoring samples via contractors.
- Train and oversee internal environmental monitoring once brought in-house.
- Serve as the subject matter expert for environmental monitoring issues and provide technical expertise aligned with current GMPs.
Day-to-Day Activities
- Manage the contract testing laboratory for microbial testing of in-process and final product.
- Oversee sample collection, shipment, receiving, and reviewing test data, and deliver the results internally.
- Oversee environmental monitoring contractors for manufacturing suites, including ensuring samples are collected at determined frequency, receiving results of sampling, and delivering results internally.
- Support the establishment of rapid microbial method testing for lot release of drug product to support internal clinical manufacturing.
- Support the set up, management, and maintenance of the Environmental Monitoring program for an internal manufacturing site.
- Support all aspects of microbial testing, from sample receipt and chain of custody through generation of CoTs.
- Provide expertise to support investigations, deviations, and CAPAs.
- Implement process improvements to support operational efficiencies.
- Promote a culture of Quality and Operational excellence.
Requirements
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external).
- Demonstrated leadership within teams producing results.
- Ability to communicate effectively in a way that fosters positive relationship building.
- Passion for addressing the critical unmet medical needs of patients.
- Self-directed individual who can work in a risk-tolerant, fast-paced, innovative environment.
Education and Experience
- At least a Bachelor's degree.
- 5+ years of relevant experience.
- Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred.
- Experience with environmental monitoring, aseptic processing, and microbial testing.
- Strong understanding of cGMP/ICH/FDA/EU guidance and regulations relating to safety testing of biologics or cell and gene therapies.
- Leading activities in microbiology laboratories that support sterile manufacturing required.
- Experience in site start-up operations is a plus.
About Regeneron Cell Medicines
Regeneron Cell Medicines (RCM) has been created to advance the next generation of cell therapies and explore combinations with Regeneron's proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing, and clinical employees based in Seattle, WA and Cambridge, MA.
