Senior Engineer, Cell Therapy Process Validation - CTO2
Menlo Park, California, United States
Cell Therapy Operations
Senior Engineer, Cell Therapy Process Validation
Location: Orchard North America, Menlo Park, CA
Reporting to: Associate Director, Validation, Cell Therapy Operations
Orchard Therapeutics is a fully integrated, leading-global commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.
Partnering with world-leading research institutions in gene therapy, Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas.
The Cell Therapy Process Validation Sr. Engineer 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 development, process characterization, and validation of manufacturing processes for lentiviral vector and cell therapy final drug product production. Core activities will focus on process characterization, formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and manufacturing controls, product and process impurity clearance, and leachable extractable assessments. These activities will support Orchards pipeline programs from pre-clinical research through to commercial including associate regulatory requirements.
- Lead characterization and validation of lentiviral production and cell therapy production including culture, transfection, and purification of lentiviral vector, and well as cell isolation, cell culture, cell transduction and cell cryopreservation of Drug Product, including:
- Design and execute studies and protocols to support process development and characterization of Lentiviral vector, cell therapy intermediate and final drug product formulation.
- Execute process characterization studies in house and lead studies execute through CMO’s, including protocol generation, in lab execution, and report documentation using GDP.
- Support activities to validate manufacturing at contract manufacturing organizations including stability evaluation, raw material evaluation, process scale-up / scale-out, Leachable and extractable assessments, residual clearance assessments, and process validation per relevant regulatory guidance.
- Lead FMEA risk assessments for cell therapy manufacturing processes
- 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, experiment with BLA and MAA submissions preferable.
- Other activities as may be assigned
The ideal candidate for this position must have experience in the development, manufacture and delivery of biologics, vectors, or cell-based therapy products with significant applied experience in the biotechnology industry. Candidate must possess:
- Experience completing modern process characterization incompliance with regulatory guidance for quality by design
- Experience managing process development and validation in support of GMP operations though contract manufacturing organizations
- Experience designing and executing process validation experiments using statistical multi-parameter design methods such as DOE
- Experience performing FMEA risk assessments
- Experience preparing documentation for regulatory filings with US and EU regulatory agencies, BLA and MAA experience preferable
- 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
- International travel required in support of CMOs.
Education & skills
- Degree in Biomedical, Bioprocessing, Chemical Engineering or equivalent Biomedical Engineering or equivalent. PhD with at least 5 years experience or BS/MS with 10 years industry experience, or in bio-processing, medical technology, or biological sciences with a primary focus on the development, manufacture, distribution and delivery of cell-based or biologic therapy products. Experience in lieu of advanced degree will be considered
- 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 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.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
For further information on this role do not hesitate to email HR@orchard-tx.com
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.