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 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)