Job Summary and Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary: Manages bioassay validation and commercial assay support function in the quality control department. Receives qualified methods from Bioassay development group, ensures their appropriateness for use, validates the methods, and implements them in the commercial QC laboratory. The group will then support those methods throughout the product lifecycle, which includes all aspects of assay lifecycle management.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Manage the bio-analytical and cell-culture validation and commercial support laboratory for drug potency analyses by in-vitro cell-based bioassays and ELISA-based binding assays. This will involve managing teams of scientists and associates to perform these activities.
• Works closely with the bioassay development group laying out the requirements and ensuring that the bioassays are ready for clinical / commercial routine resting environment.
• Work with relevant SMEs from IOPS and Tarrytown as well as laboratory management to determine best practices for bioassay and binding assay design and execution.
• Coordinate activities with the QC Assay validation manager, ensuring consistent timelines and priorities for all validations and method transfers.
• Receive assays from bioassay development and implement them in the QC laboratory. This will involve validation and transfer activities.
• Support assay validation by designing experiments that are in compliance with ICH and other applicable guidelines and ensuring timelines are met.
• Support bioassay method transfer activities into QC, within QC, and from QC to external partners.
• Approve investigations into atypical and OOS test results obtained during product testing.
• Review/approve test results and write/approve technical reports.
• Represents QC at meetings to keep informed of manufacturing and clinical development needs and priorities, and provide analytical information and expertise.
• Using statistically based methods help to design data treatment methods, assay validity and acceptance criterion for bioassays.
• Stays current in the state of the art by attending and presenting at relevant industry conferences and workgroups. Coordinates with members of Analytical Sciences, Manufacturing, Stability, and Business Ops to provide analytical support.
• Manages QC Scientists, distributes work load, and monitors progress. Ensures training is appropriate and stays up to date.
• Maintains Project Management of Method transfer and validations. Report progress monthly to upper management and reports any deficiencies.
• Ensures lab compliance with applicable cGMP regulations and SOPs.
• Ensures that safety standards are maintained.
• Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations.