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Manager of Process Science/Process Engineering, Manufacturing Sciences MSAT

4 months ago


San Diego, United States Talentry LLC Full time

Job DescriptionManager of Process Science/Process Engineering, Manufacturing Sciences MSATSan Diego, CADirect Hire. 160-180kTalentry is looking for a skilled Manager of Process Science with proven TFF and Fill/Finish experience to work for a successful and growing therapeutic 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 commercial cGMP manufacturing. They will lead teams and projects, as well as provide leadership and subject matter expertise, pertaining to product introduction, process performance and improvement and Product Lifecycle Management (PLM).This leader will author and review documents, including SOPs, batch records, process reports, tech transfer procedures, BoM, etc. They will also provide the expertise necessary for buffer formulation, TFF, filtration, fill/finish, lyophilization, and packaging/labeling.RequirementsBS and 8+ years, or Ph.D., and 4+ years of Process Engineering in 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.Excellent communication skills. Willingness to travel up to 40%BenefitsExcellent salary (160-180k) and benefits in this growing company.