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Car T Process Engineer (West Orange,NJ)

Company: Celgene
Location: West Orange
Posted on: May 19, 2019

Job Description:

Req #:
Location: Offsite, New Jersey, United States
Job Category: Technical Development
Work Location: OFFSITE
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular
Job Summary
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 team in Global MSAT. The successful candidate will be based at one of our CMO sites in Houston, TX and collaborate with the US-based GMSAT team to lead efforts related to continuous commercial manufacturing of our viral vector process. This engineer will have responsibilities like an internal MSAT organization for Celgene s viral vector manufacturing CMO site in Houston, TX with the focus on supplementing the technical capabilities of the CMO. This person may be responsible for and support processes from early clinical phase through PPQ and commercial manufacturing support. This person will collaborate across all CMC functional areas to ensure 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 commercialization and evolution of viral vector processes.

Primary Responsibilities

  • 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 eventsRequired Qualifications
    • Demonstrated ability to effectively work in cross functional teams 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/characterization of biologics and/or cell therapy manufacturing processes.
    • Experience with cGMP, ICH guidelines, PPQ (process validation).
    • 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.
    • Experience working with CMOs or external partners very desitableEducation requirements
      • MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 4+ years relevant experience in biologic process development or commercial biologic manufacturing support.
      • Knowledge of cellular immunology a plus.About Us

        COMMITTED 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. Associated topics: biochemistry, bioinformatic, biological engineer, biomechanics, biomedical, bioprocessing, biosynthetic, fermentation, msat, neurodegenerative

Keywords: Celgene, New York , Car T Process Engineer (West Orange,NJ), Engineering , West Orange, New York

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