Manager of Process Science/Process Engineering,Manufacturing Sciences MSAT

San Diego, CA

Direct Hire. 160-180k

Talentry is looking for a skilled Manager of Process Sciencewith proven TFF and Fill/Finish experience to work for a successful and growingtherapeutic biotech company in San Diego.

The right person for this role will ensure the successful implementation,scale-up, and tech-transfer of drug product therapy for clinical and commercialcGMP manufacturing. They will lead teams and projects, as well as provideleadership and subject matter expertise, pertaining to product introduction,process performance and improvement and Product Lifecycle Management (PLM).

This leader will author and review documents, includingSOPs, batch records, process reports, tech transfer procedures, BoM, etc. Theywill also provide the expertise necessary for buffer formulation, TFF, filtration,fill/finish, lyophilization, and packaging/labeling.

Requirements

BS and 8 years, or Ph.D., and 4 years of Process Engineeringin a similar role.

Proven leadership/mentorship experience.

Solid tech-transfer track record, with a history of cGMP compliance.

Proven drug product manufacturing, fill/finish processing,optimization.