Seattle, Washington Req #: 1902035
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 II/III to join our Vector & Gene Delivery MSAT team in Global MSAT. The successful candidate will support efforts related to transfer of manufacturing technologies from process development and responsibilities of lifecycle management thereafter. 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.
- Support process and technology transfers, change management, and technical process support for cell therapy and vector products
- Support development of process control strategies including execution of process risk assessments, development of range justifications, and development of continued process verification strategy
- Author regulatory filings across product lifecycle
- Perform and support data monitoring of manufacturing processes to understand process capability, troubleshoot investigation-driven events
- Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within Juno unit operations
- Support design activities for clinical and/or commercial facilities
- Support efforts focusing on alignment and harmonization of manufacturing process across multiple sites
- Leverage and maintain strong relationships with external partners
- 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), control strategy development, 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 4 to 8 years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support
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.