Menlo Park, California, United States
Cell Therapy Operations
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 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.
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:
Education & skills
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
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.