Car T Process Engineer (Trenton,NJ)
Posted on: May 26, 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 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
- 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
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
- Experience in development/characterization of biologics and/or
cell therapy manufacturing processes.
- Experience with cGMP, ICH guidelines, PPQ (process
- 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
- Experience working with CMOs or external partners very
- 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
- 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:
bioengineering, biomedical engineer, bioprocessing, biosynthetic,
genetic, hereditary, nutrition, pain, pharmaceutical,
Keywords: Celgene, East Brunswick , Car T Process Engineer (Trenton,NJ), Engineering , Trenton, New Jersey
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