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 Master’s 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)

Kennedy Bond

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Associate Director, MS&T – Aseptic Fill Finish