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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Manage the bioassay clinical testing function in the quality control (QC) department. Receives qualified methods from Bioassay development group, ensures their appropriateness for use, co-qualifies the methods, and implements them in the clinical QC laboratory. As the product moves into late phase, the group will be responsible for transferring methods to commercial testing laboratory.
Education and Experience:
Essential Duties and Responsibilities include, but are not limited to, the following:
* Manages the bio-analytical and cell-culture cGMP clinical testing laboratory for drug potency analyses by in-vitro cell-based bioassays and ELISA-based binding assays.
* 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 as well as laboratory management to determine best practices for bioassay and binding assay design and execution.
* Coordinate activities with method development team, QC Commercial Testing Manager and Assay validation manager, ensuring consistent timelines and priorities for all method transfers and validation-readiness.
* Receive assays from bioassay development team and implement them in the QC Clinical laboratory. This would involve transfer and potentially co-qualification activities.
* Support bioassay method transfer activities into QC, within QC, and from QC to external partners.
* Support reviewing, drafting and revisions of bioassay related SOPs in association with development group.
* Support and 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 understand manufacturing and clinical development needs and priorities, and provide analytical information and expertise.
* Using statistically based methods to support designing of 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 associates, testing schedules, distributes work load, and monitors progress. Ensures training is appropriate and stays up to date.
* Maintains Project Management of Method transfers. 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.
Knowledge, skills and abilities:
*Ability to work independently or on a team.
*Strong analytical and protein chemistry background
*Strong presentation and communication skills
*Ability to prioritize, manage multiple tasks, and meet deadlines.
* Requires a minimum of BS/BA in cell biology, biochemistry, or related field and 7+ years of relevant experience in a biotech or pharmaceutical laboratory.
* Previous management experience required.
* Strong technical background, analytical and writing skills, and hands-on experience in a biology laboratory are must.
* Experience in a GMP environment preferred.
* Level will be determined based on experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.