Cell Therapy Process Development Associate - Innovative Gene Therapy Start Up

Menlo Park, California, United States · Cell Therapy Operations expand job description ↓

Description

Location: Menlo Park, CA

Reporting to: Manager, Cell Therapy Operations


The Cell Therapy Process Development Associate will perform processing and testing related to the development, manufacture and delivery 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. This role is ideal for an Development Associate that is looking to work in a small team, where a person’s contribution is valued. The team is going through an exciting start-up phase, where everyone is fully involved in the development of the team dynamics.


RESPONSIBILITIES

  • Carry out development, scale-up and optimization testing 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
    • Contribute to the compilation and review of master production records, standard operating procedures, development/validation protocols and reports
    • Provide technical support for batch record review and associated documentation for release of gene-modified cell therapy products. Support investigations for release of gene-modified cell therapy products as required
  • Participate in cross-functional activities with 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
  • Provide data summaries for 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 cell-based therapy products with significant applied experience in the biotechnology industry.

Candidate must possess:

  • A minimum, BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences. Advanced degree preferable
  • Minimum of 5 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
  • 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 CMOs
  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
  • This position requires on site person-in-plant presence at CMOs and contract vendors on a potential global basis. Therefore, ability to travel is a pre-requisite
  • 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 facility commissioning, and production equipment design 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.

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