Scientist, Process Validation
Scientist, Cell Therapy Process Validation
Reporting to: Associate Director, Cell Therapy Operations
Location: Menlo Park, CA
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. Orchard is a fast-growing and well-funded company with ground-breaking science and a broad pipeline that includes several products in late stage development and at least one BLA planned for the coming year.
The Cell Therapy Process Validation Scientist will lead activities for development, scale up, optimization, and validation 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.
- Lead development, scale-up, optimization, and validation 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
- Perform FMEA risk assessments for cell therapy manufacturing processes
- 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
- B.S. or higher level degree in a scientific discipline preferred
- At least 5 years of experience in Regulatory Affairs, ideally in biologics
- Working knowledge and understanding of FDA regulations and guidelines
- Exposure to a global cross-functional team environment
- Excellent organizational skills and strong attention to detail; and ability to prioritize effectively and handle multiple tasks
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact efficiently with Regulatory Authorities
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including an annual bonus and a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; and access to a voluntary 401(k) with company match. Orchard Therapeutics is an equal opportunity employer.
To apply for this role, or for further information, please email email@example.com
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.