Associate Director QC Bioassay Development
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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: Manages bioassay development function in the quality control department. Translates research assays into QC ready methods, qualifies those methods and transfers them to clinical 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.
•Serve as analytical lead on the CMC development team for multiple clinical programs.
•Assist in 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.
•Stays current in the state of the art by attending and presenting at relevant industry conferences and workgroups.
Knowledge, Skills and Abilities:
•Ability to maintain integrity and honesty at all times
•Ability to work independently or as part of a team
•Ability to communicate and lead with transparency
•Continuously drive to improve processes
•Demonstrate respectful behavior at all times
•Lead department for optimal performance and set course for future
•Accountable for performance and results of department
•Business continuity and long-term planning
•Ability to influence outside of own department
•Create departmental goals and assign resources based on business needs
•Effectively communicate vision for department
•Evolving knowledge of global organization and industry trends
Education and Experience:
•Requires BS/BA in cell biology or biochemistry, or related field. Ph.D highly preferred.
•Requires 10+ years of biotech or pharmaceutical laboratory experience, with 3-5 years of management experience.
•Requires strong CMC background, analytical and writing skills, and hands-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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.