Seattle, Washington Req #: 1901595
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Employee Status: Full-time
Job Type: Regular
Celgene is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
Celgene is growing, and we are looking for a Process Engineer III to join our Vector & Gene Delivery MSAT team in Global MSAT. This Seattle based position will initially support our viral vector manufacturing CMO in Houston, TX and will have MSAT responsibilities focused on supplementing the technical capabilities of the CMO. Significant travel is expected for the first two years.
The successful candidate will support efforts related to transfer of manufacturing technologies from process development and responsibilities of lifecycle management. The Process Engineer will be responsible for supporting the transfer of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), training of personnel, change control ownership, and other quality system related deliverables.
This person may be responsible for supporting processes from early clinical phase through development of PPQ strategies and commercial manufacturing support. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Engineer II/III will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products.
- Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
- Review executed batch records to ensure process is operating within the validated state
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Work with technical and quality teams at CMO to evaluate and implement process improvements
- Author risk assessments and technical reports and revise process documents as needed to support process changes
- Provide on-site technical process support for ongoing manufacturing
- Perform and support data monitoring of manufacturing processes to understand process capability and troubleshoot investigation-driven events
- Approximately 50%
- Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
- Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
- Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.
- Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Excellent problem solving skills.
- Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
- Able to creatively manage time and elevate relevant issues to project lead and line management.
- Strong scientific and technical writing.
- Detail oriented with excellent verbal and written communication skills.
- MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 6+ years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
- Knowledge of cellular immunology a plus.
About UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.