Process Development Associate, Cell Therapy

The Cell Therapy Process Development Associate will perform activities for development, scale up, optimization, and validation of Orchard Therapeutics' innovative gene-modified cell-based therapeutic products. Such activities will include process development, process characterization, and validation of manufacturing processes for lentiviral vector and cell therapy final drug product production. Core activities will focus on process characterization, formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and manufacturing controls, product and process impurity clearance, and leachable extractable assessments. These activities will support Orchards pipeline programs from pre-clinical research through to commercial including associate regulatory requirements.

Responsibilities

• Lead characterization and validation of lentiviral production and cell therapy production including culture, transfection, and purification of lentiviral vector, and well as cell isolation, cell culture, cell transduction and cell cryopreservation of Drug Product, including:
  • Design and execute studies and protocols to support process development and characterization of Lentiviral vector, cell therapy intermediate and final drug product formulation.
  • Execute process characterization studies in house and through CMO's, including protocol generation, in lab execution, and report documentation using GDP.
  • Support activities to validate manufacturing at contract manufacturing organizations including stability evaluation, raw material evaluation, process scale-up / scale-out, Leachable and extractable assessments, residual clearance assessments, and process validation per relevant regulatory guidance.
  • Perform FMEA risk assessments for manufacturing processes
  • Prepare protocols and reports for prospective qualification and validation activities
  • Ensure the successful execution of activities performed between departments and company designated collaborators and CMO's
  • Contribute to CMC / CTD documents for regulatory filings with US and EU regulatory agencies
• Other activities as may be assigned

Requirements

The ideal candidate for this position must have experience in the development, manufacture and delivery of biologics, vectors, or cell-based therapy products with significant applied experience in the biotechnology industry. Candidate must possess:

• Experience completing modern process characterization incompliance with regulatory guidance for quality by design
• Experience managing process development and validation in support of GMP operations
• Experience designing and executing process validation experiments using statistical multi-parameter design methods such as DOE
• Experience performing FMEA risk assessments
• Experience contributing to documentation for regulatory filings with US and EU regulatory agencies
• Experience with the set-up and technology transfer of manufacturing processes and controls at international CMOs
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

Education & skills

• BS/MS in Biomedical, Bioprocessing, Chemical Engineering or equivalent with at least 5 years of industry experience in bio-processing, medical technology, or biological sciences with a primary focus on the development, manufacture, distribution and delivery of cell-based or biologic therapy products. Experience in lieu of advanced degree will be considered
• Proven personnel and project management skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• Ability to operate in a fast-paced, multi-disciplinary industrial environment
• Experience of GMP production equipment operation and validation, including IQ, OQ & PQ a plus

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify