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 Senior Process Engineer or the Principal Process Engineer (the exact title will be based on experience and expertise). This position will report to the Director, MSAT, and be responsible for the technical transfer (to internal and external manufacturing) and the on-the-floor support to clinical manufacturing.

Key Responsibilities

• Lead technical transfer to internal manufacturing or CDMO, including but not limited to, authoring tech transfer protocol, managing timelines, and training manufacturing staff.
• Provide scientific and technical expertise to ensure flawless execution of manufacturing operations and leadership of complex investigations and continuous improvements.
• Partner with Manufacturing, Process Science, Quality, Supply Chain, and other teams to ensure successful GMP manufacturing.
• Participation in deviation, out-of-specification, and change control management, ensuring compliance with internal standards and regulatory requirements.
• Continuously monitor, anticipate, and proactively resolve issues that may arise during GMP manufacturing.
• Author batch record, SOP, WI, and technical reports, and prepare technical presentations as needed.
• Support regulatory filings and product life cycle management and contribute to process characterization and PPQ.

Qualifications

• B.S. or M.S. in Biomedical Engineering, Bioengineering, Chemical Engineering, Biotechnology, or Process Science/Engineering with 4+ years of clinical or commercial manufacturing experience in the biopharma industry.
• Experience in a cell therapy and/or viral vector manufacturing environment is strongly preferred.
• Demonstrated proficiency in evaluating data, authoring, and reviewing the batch record and other documents, and communicating results within the team and to other stakeholders is preferred.
• 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 preferred.
• Demonstrated proficiency in the use of Operational Excellence and Lean Six Sigma techniques.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.
• Experience with process characterization and PPQ is a plus.
• Experience working in a self-driven, performance/results-oriented, fast-paced matrix environment.
• Capability to creatively manage time and elevate relevant issues to project lead and line management.
• Detail-oriented with excellent verbal and written communication skills.