Senior Staff Scientist-Formulation/AAV/Gene Therapy Product Development

Compensation

: $96,900.00 - $143,000.00 /year *

Employment Type

: Full-Time

Industry

: Healthcare - Allied Health



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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: The Formulation Development Group is seeking for a subject matter of expert in the areas of formulation and product development of gene or cell therapies, at Senior Staff Scientist level, to lead functional support to Adeno-Associated Virus (AAV) based gene therapy product development from research, preclinical development to clinical development and commercialization. The Senior Staff Scientist will be mainly responsible for AAV based gene therapy drug product formulation and product design and development and serve as the functional point of contact for internal and external collaborations in gene therapy product development and manufacturing. In addition, the Senior Staff Scientist will interact with the other research and development functions to carry out research on developing new formulation, delivery, process and technologies for gene therapy, cell therapy and other new biologic drug products. Responsibilities: Lead development of stable drug substance and drug product formulations for preclinical and clinical projects. Support the platform development for gene therapy product within Research and Development. Serves as a functional representative/SME in AAV based gene therapy drug development within the company to support internal development and collaboration with external development and manufacturing partners. Establish fit-for-purpose analytical methods to support formulation development, process development, and research stability testing. Design and execute stability and characterization studies for drug substance and drug product. Support fill finish process development and technology transfer to the drug product manufacturing sites Authors and reviews formulation and product development related regulatory and technical documents, study reports and technology transfer documents. Lead, guide and collaborate with other scientists in conducting research and developmental work, and investigating and solving developmental problems. Sets goals, assigns tasks, and provides performance management and development as needed. Lead research toward developing platform formulations and manufacturing process for AAV products. Develop and implement long term strategy in developing gene therapy products for commercialization. Participate in operational collaborations with Regeneron groups or academic collaborators; build cross departmental gene therapy expertise across Regeneron via collaboration and pro-active leadership. Requirements: Ph.D. in Chemistry, Biology, Chemical Engineering, Biochemistry, Pharmaceutical Science (or related discipline) with 5-7 plus years of relevant industry experience. Prior experience with gene therapy product development is required. Previous experiences working with protein biologics or cell therapy products are plus. Experience in working with contract manufacturing organization (CMDO) is highly desirable. Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC, UPLC, column chromatography) and qPCR/ddPCR methods, biophysical techniques (DLS, AUC, particle analysis, etc.) for protein and AAV characterization are plus. Demonstrated track record of publications and patents. Excellent interpersonal, verbal and written communication skills. Ability to think critically and demonstrated troubleshooting and problem-solving skills.Salary Range: NAMinimum Qualification5 - 7 years
Associated topics: bio, bioinformatic, biological engineer, biomedical, enzyme, fermentation, genetic, hereditary, molecular, msat * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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