Director, Cell Therapy Manufacturing Operations
Adicet is developing the next generation immunotherapies by generating a pipeline of allogeneic gamma delta T cell products engineering with CAR or TCR. In addition,
Adicet's immune cell platform is complemented by its ability to identify and validate novel disease specific peptide-MHC targets and generates T cell receptor-like antibodies directed against these disease-specific peptide MHC complexes.
Adicet Bio was founded in late 2015 with significant investment from OrbiMed, Novartis Venture Funds and Pontifax. In August 2016, Regeneron and Adicet Bio announced a strategic collaboration to discover and develop next-generation engineered immune-cell therapeutics and in September 2016, Adicet Bio was recognized and named by FierceBiotech as a "Fierce 15" Biotech Company of 2016.
DIRECTOR, CELL THERAPY MANUFACTURING OPERATIONS
Adicet Bio is seeking a highly motivated and experienced individual to lead the Process Development function. This individual will be responsible for organizing and executing technology transfer of cell therapy product manufacturing processes and controls to our Contracting Manufacturing Organization (CMO) partners. This individual will then be responsible for the ongoing oversight of manufacturing operations with the CMOs.
With a strong background in cell and gene therapy process development and manufacturing, this individual will have proven experience working with/as a CMO. The individual will serve as the technical lead and manager for a team of Process Development Engineers. This role will require regular, collaborative interactions with Adicet's Analytical Development, Viral Vector Production, Quality Assurance and External Manufacturing Supplier Relationship teams.
Reporting to the Head of Technical Operations, this individual will be responsible for:
- Assisting in definition of the strategy to develop a platform process for the manufacture of Adicet's cell therapy products suitable for BLA and commercialization
- Leading execution of platform process development
- Leading the technology transfer of cell therapy product manufacturing processes and controls from Process Development into CMOs
- Compiling and reviewing master production records, standard operating procedures, transfer protocols and reports
- Providing on-site technical support, person-in-plant and general oversight of manufacturing operations at the CMO
- Reviewing batch records and associated documentation for release of gene-modified cell therapy products
- Leading the investigation of deviations and risk assessments at CMOs
- Driving accountability with the process development team by creating and articulating a clear plan of action aligned to the Corporative Objectives, guiding the daily activities of the team and providing ongoing feedback at an individual and team level.
- Ensuring cross-functional collaboration with peers to solve complex problems, investigations and risk assessments
- Providing trending and process performance analytics with recommendations for improvements in efficiency and cost of goods
Note: This role will require the ability to travel; initially within the US and subsequently internationally.
- BS or equivalent degree in bioprocessing, medical technology, chemical engineering, or biological sciences is required
- 10 plus years of experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products
- 8 plus years of increasing responsibility in managing and leading a team of process development engineers and manufacturing teams
- Experience with the set-up, technology transfer and execution of manufacturing processes and controls at CMOs
- Experience with the direct management of technology transfer and subsequent manufacture of cell therapy product at CMOs, including person-in-plant
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
- Experience designing efficient studies with proven endpoints using computational design of experiment (DOE) methods
- Expertise influencing across functions and teams to achieve organizational objectives
- Experience preparing documentation for regulatory filings with US and EU regulatory agencies
- Demonstrated technical and strategic leadership and problem-solving skills
- Ability to work independently and as part of a team with exceptional ability to collaborate and lead
- Experience presenting complex concepts to all levels of the organization, with proven ability to clearly articulate a point of view and recommendation
- Ability to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values (fearless, accountable, collaborative)
- Expertise in staffing, budgeting and expense management
- Proven project management capability with a track record of meeting timelines is required
- Excellent written and oral communication skills to influence effectively across the organization and with CMOs
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.