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: Perform bioassay development, characterization, optimization, transfer, validation and investigation for QC. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Education and Experience:
Essential Duties and Responsibilities include, but are not limited to, the following:
* Perform bioassay development/validation for QC. Troubleshooting existing bioassays in commercial and clinical portfolio.
* Review new test procedures and assays.
* May evaluate and bring in new methodologies/techniques when needed.
* Facilitate assay transfer from R&D and to business partners.
* Organize analytical assay transfer internally and externally.
* Set product specifications.
* Participate in technical troubleshooting and problem investigation.
* Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
* Participate in training programs for analysts.
Knowledge and skills:
* Ability to work independently or on a team.
* Ability to prioritize, manage multiple tasks, and meet deadlines.
* Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
* Requires Ph.D in Biochemistry, Chemistry, Biology or related field; may consider another degree discipline, and 3+ plus years relevant experience. cGMP experience is preferred.
Previous cell culture and tissue culture experience is required.
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.