Career Opportunities in the Foresite Capital Network

ImmPACT Bio is looking for a proactive, strategic, and hands-on individual to join our growing team as the Associate Director, MSAT. This position will report to the Director, MSAT, and be responsible for the technical transfer and lead technical support to internal and external manufacturing.

Primary Responsibilities:

• Lead and manage technical transfer to internal manufacturing or CDMO, including but not limited to, developing tech transfer strategy, authoring tech transfer protocol, performing gap assessment, planning and managing resources, managing timelines, and training manufacturing staff.
• Leverage project management skills and technical expertise to troubleshoot on-the-floor problems in real-time and investigate and properly escalate complex issues to senior management to ensure smooth manufacturing.
• Develop gap assessment and risk management strategies and continuously monitor, trend, anticipate, proactively mitigate, and resolve roadblocks that may arise during GMP manufacturing.

• Partner with Manufacturing, Process Science, Quality, Supply Chain, and other teams to ensure successful product manufacturing and delivery to clinical sites.
• Provide technical leadership in deviation, out-of-specification, and change control management, ensuring compliance with internal standards and regulatory requirements.
• Support regulatory filings and product life cycle management and contribute to process characterization and PPQ.

Basic Qualifications:

• B.S. in Biomedical Engineering, Bioengineering, Chemical Engineering, Biotechnology, or Process Science/Engineering with 12+ years (M.S. with 10+ years) of clinical or commercial manufacturing experience in the biopharma industry.
• Solid experience in leading tech transfer, collecting and evaluating data from external manufacturing partners like CDMO, troubleshooting process issues/problems, authoring, and reviewing the batch record and other documents, and communicating results within the team and to other stakeholders is required.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects is required.
• A solid understanding of the fundamentals of ICH and other industry guidelines supporting product life cycle management, with a proven ability to assimilate data and grow product knowledge into the broader aspects of CMC development and lifecycle management is strongly preferred.
• Experience in cell therapy and/or viral vector GMP manufacturing environment is strongly preferred.

• Detail-oriented with excellent verbal and written communication skills is preferred.
• Experience with process characterization and PPQ is preferred.
• Demonstrated proficiency in the use of Operational Excellence and Lean Six Sigma techniques is a plus.
• Experience working in a self-driven, performance/results-oriented, fast-paced matrix environment is a plus.