Cell Therapy Process Development Scientist - Innovative Gene Therapy Start Up

Location
Menlo Park, California
Posted
Jun 22, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

DESCRIPTION

The Cell Therapy Process Development Scientist will lead activities for development, scale up and optimization of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include process and assay development, cell therapy intermediate and final drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls to support company’s product programs from pre-clinical research through to commercial.

ESSENTIAL FUNCTIONS:

  • Lead development, scale-up and optimization of cell isolation, cell culture, cell transduction and cell cryopreservation processes to include:
    • Process and assay development, cell therapy intermediate and final drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls
    • Compile, review and edit master production records, standard operating procedures, development/validation protocols and reports
    • Provide SME review of executed batch, records, test records and associated documentation for release of gene-modified cell therapy products. Support investigations
    • Co-ordinate activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
    • 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
    • Prepare CMC / CTD documents for regulatory filings with US and EU regulatory agencies
  • Other activities as may be assigned

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

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

  • PhD in Biomedical Engineering or equivalent with at least 5 years of postdoctoral industry experience in bioprocessing, medical technology, or biological sciences with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products. Experience in lieu of advanced degree will be considered
  • Experience managing process and assay development and validation in support of GMP operations
  • Experience preparing 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

OTHER REQUIREMENTS:

  • 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 cell processing production equipment operation and validation, including IQ, OQ & PQ a plus

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.