The company is seeking a highly motivated leader with relevant experience to work on innovative T cell therapy products. The Director, Process Development will
- Provide process development and CMC leadership for new product development, technology transfer and GMP manufacturing for engineered autologous T cell therapy products.
- Manage CMC activities and be accountable for manufacturing and development protocols, production procedures, and process development activities, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
- Work with the development group to design and scale-out cell therapy processes, lead CMC activities, as well as draft documentation for regulatory filings to advance the product portfolio.
- Interact cross-functionally to support research, process development and process characterization of The Company’s T cell products, as well as lead technical investigations.
Responsibilities include, but are not limited to:
- Lead CMC activities in support of engineered T cell products, including oversight of cross-functional teams
- Draft, review and approve technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing).
- Manage cross-functional development teams to advance production activities
- Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
- Oversee activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
Experience and Qualification Requirements:
- Ph.D in Biochemistry, Chemical Engineering, Biotechnology or equivalent is preferred
- Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Must have 6+ years of pharmaceutical manufacturing, technology transfer & process development experience
- Mastery of scientific and engineering principles
- Practical experience in GMP operations
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Read and interpret drawings such as blueprints, AutoCAD, P&ID, PLC
- Well-developed computer skills
- Pharmaceutical products GMP manufacturing experience is a must
- Cell culture or aseptic processing experience is a plus
- Previous experience with cell therapy products is a plus
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT’s lead program, a bispecific “OR-gate” CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.
ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company.