Car T Process Engineer (East Brunswick,NJ)
Location: East Brunswick
Posted on: June 7, 2019
Location: Offsite, New Jersey, United States
Job Category: Technical Development
Work Location: OFFSITE
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
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
- Perform and support data monitoring of manufacturing processes
to understand process capability and troubleshoot
- Approximately 50%Required Qualifications
- 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
- 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
- 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
- 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
\"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: bio,
bioengineering, bioprocess, hereditary, medical, metabolic, msat,
nutrition, pathogenesis, pharmaceutical
Keywords: Celgene, East Brunswick , Car T Process Engineer (East Brunswick,NJ), Engineering , East Brunswick, New Jersey
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