Scientist, Tech Transfer & Manufacturing Support

Role Summary

Scientist, Upstream Tech Transfer facilitates the transfer of upstream bioprocesses from development to GMP clinical or commercial manufacturing. In this role, you will ensure the successful scale-up and implementation of upstream processes, including vial thaw, seed expansion, production fed batch cell culture, and harvest. With responsibility spanning clinical and commercial interfaces, this role offers broad cross-functional engagement and significant organizational exposure.

Responsibilities

• Lead USP tech transfer activities throughout the lifecycle of the program to internal and/or external manufacturing sites.
• Serve as liaison between Drug Substance Development (DSD) and receiving sites.
• Provide technical support to manufacturing operations and assist in troubleshooting process and equipment issues; provide process/product impact statements in support of manufacturing deviation investigations.
• Prepare/review/approve technical documents including development/tech transfer reports, protocols, batch records, SOPs (Standard Operating Procedures) and CMC (Chemistry, Manufacturing and Control) regulatory submissions (IND, BLA, MAA etc).
• Interact cross-functionally with manufacturing, quality assurance, regulatory affairs, facilities, and other internal and external functions to support successful process development and manufacturing of drug substance.

Qualifications

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
• B.S. or B.A. in Chemistry, Biology, or related field
• Minimum of 8 years’ experience with Bachelor’s degree or minimum of 6 years’ experience with Graduate degree, within the pharmaceutical industry
• Experience working on mammalian cell culture in laboratories or production in the pharmaceutical industry, with expanded levels of responsibility.
• Ability to build effective working relationships across teams and organization levels
• Excellent verbal and written communication skills
• Familiarity with cGMP principles
• Ability to travel to manufacturing facilities, as needed (up to 15%)