Cell Therapy Process Development Associate - Innovative Gene Therapy Start Up
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.
- 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
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
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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