Associate Director QC Bioassay Development

Company Name:
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.
Manages bioassay development function in the quality control department. Translates research assays into QC ready methods, qualifies those methods and transfers them to commercial QC laboratory.
Essential Duties and Responsibilities include, but are not limited to, the following:
Direct the bio-analytical and cell-culture laboratory for developing clinical phase drug potency analyses by in-vitro cell-based bioassay and ELISA-based binding assay. This will involve hiring teams of scientists and associates to perform these activities.
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.
Receive research assays from R&D for clinical candidates and optimize them for QC. Oversee qualification of these assays for Phase I.
Set up process and team to perform Phase I and IIa release and stability testing of the above mentioned methods.
Approve investigations into atypical test results obtained during product testing.
Support assay development and validation by designing experiments.
Review/approve test results and write/approve technical reports.
Represents analytical sciences at meetings to keep informed of manufacturing and clinical development needs and priorities, and provide analytical information and expertise.
Trains junior staff and direct laboratory work to show proof of concept for new ideas.
Ensures lab compliance with applicable cGMP regulations and SOPs.
Using statistically based methods help to design data treatment methods, assay validity and acceptance criterion for bioassays and other product release assays.
Creates monthly testing reports.
Completes monthly cGMP compliance inspection report.
Stays current in the state of the art by attending and presenting at relevant industry conferences and workgroups.
Experience and Required Skills:
Education and Experience:
Minimal BS/BA in cell biology or biochemistry, or related field and Ph.D is highly preferred.
Require 10+ years of biotech or pharmaceutical laboratory experience, with 3-5 years of management experience.
Strong CMC background, analytical and writing skills and hands-on experience are must.
A proven leader, communicator, organizer and problem solver.
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 Regenerons 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.
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