Cell Therapy Process Development Associate - Innovative Gene Therapies
Reporting to: Manager, Cell Therapy Operations
Location: Menlo Park, CA
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
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
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.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.