Associate Director, MS&T Aseptic Fill Finish

Associate Director, MS&T Aseptic Fill Finish Our client is pioneering a transformative approach to biologic drug delivery for patients. Their cutting-edge platform allows for higher-concentration delivery, overcoming the limitations of traditional intravenous therapies. This technology supports various protein modalities, providing a versatile solution with broader therapeutic applications. Key benefits include extended shelf life, enhanced stability, subcutaneous self-administration, and reduced injection volumes, all of which contribute to a better patient experience. Their achievements have attracted significant investment, with multiple funding rounds fueling projects now advancing toward commercialization. In support of these efforts, they have built a new GMP facility and are seeking a skilled Associate Director to join their MSAT team an manage bulk fill-finish and aseptic processing. The successful candidate will also be responsible for Main responsibilities : Managing a team of 4-5 direct reports Support pilot plant operations until workload expands into fully functioning manufacturing sciences and technology division Most crucial aspects will be managing aseptic full finish and bulk fill finish processes Ensuring GMP requirements align with FDA compliance metrics Overseeing CMOs/working alongside them, conducting risk analysis, identify process improvement, tech transfer, and deviations Reviewing documentation providing necessary input Writing master batch records/batch record release Determining critical process parameters /critical quality attributes are in place and documented Conducting risk analysis with CMO Experience : Minimum undergrad degree (Chemistry, Chemical Engineering, Biomedical Engineering or similar scientific discipline), with a Masters degree 7-10 years of industry experience across Biotech, Pharma, or CDMO At least 5 years of aseptic fill finish experience, or bulk fill finish Functional experience in Pilot Plant Operations, MS&T, Process Engineering (downstream), Formulation Development Large Molecule background, or Gene, or Cell Therapy Other technical proficiency in Tech Transfer, CDMO Management, and working knowledge of GLP Evidence of managerial responsibility (at least 3 years experience, managing 4+ direct reports)

Created: 2024-11-12