Manager / Sr. Manager, Cell Therapy Process Development

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.

MGR/SR MGR, CELL THERAPY PROCESS DEVELOPMENT

Adicet Bio is seeking a highly motivated and experienced individual with a strong background in cell therapy process and product development to manage the Process Development team. This individual will be responsible for managing the design, development, and optimization of manufacturing processing steps for an immune cell therapy product.

With a strong background in cell and gene therapy process development and manufacturing, this individual will have management experience leading cell therapy product development activities including new process/platform development, process optimization and characterization. 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.

KEY RESPONSIBILITIES

Reporting to the Director of Cell Therapy Manufacturing Operations, this individual will be responsible for:

• Design, execute, analyze and report studies for:
  • The development, scale-up/-out, optimization and validation of cell isolation, cell culture, cell transduction and cell cryopreservation processes and controls
  • Definition of process robustness, key process indicators, and critical process parameters
  • Evaluation of raw materials and development of raw materials and specifications
  • Characterization and validation of manufacturing processes and controls

• Compile and review master production records, standard operating procedures, and development protocols reports
• Provide technical support for
• Technology transfer and implementation of manufacturing processes and controls at Contracting Manufacturing Organizations (CMOs) including on-site technical support
• Review of batch records and associated documentation for release of gene-modified cell therapy products
• Support of investigations and risk assessments at CMOs
• 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.

QUALIFICATIONS

• BS or equivalent degree in bioprocessing, medical technology, chemical engineering, or biological sciences is required
• 5 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
• 2 plus years of experience managing and leading a team of process development engineers
• Experience with the technology transfer 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
• 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 ability to collaborate and lead
• Ability to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values (fearless, accountable, collaborative)
• Proven project management capability with a track record of meeting timelines is required
• Excellent written and oral communication skills

BENEFITS

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.