OXB
Process Engineer II (MSAT)
Join OXB to lead the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing of cell and gene therapy platform drug substances and products.
Responsibilities
Serve as the downstream (clarification, chromatography, TFF, sterile fill/finish) technical support for the vector manufacturing process in MSAT.
Technology Transfer Technical Leader for cross‑functional team.
Lead introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of multiple cell and gene therapy platform drug substances and products.
Lead information transfer and gap assessment for new process and method transfers.
Support MSAT and Manufacturing documentation drafting/review with a strong understanding of equipment, critical process parameters, in‑process testing, etc.
Provide guidance and lead facility fit assessments of manufacturing processes in production suites, using FMEA or similar risk‑based approaches to troubleshoot processing issues.
Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols.
Provide guidance in documentation of events and deviations during cGMP manufacturing production.
Provide guidance for process equipment onboarding.
May support other tasks as determined by management.
Qualifications
BS/MS in Engineering or related field, or Biological Science with 0‑3 years of experience in a technical engineering role or related areas.
0‑3 years of experience in pharmaceutical or biologics industry in process development or manufacturing operations.
Experience implementing special projects related to operational process improvement.
Strong leadership, relationship management, and organizational planning skills.
Ability and willingness to learn and adapt skillsets for various areas of MSAT.
Knowledge of cGMP compliance around bioprocess drug substance manufacturing.
Experience with bioprocess drug substance manufacturing process development and CGMP manufacturing.
Experience in monoclonal antibody production and purification process development is a plus.
Technical expertise in upstream/downstream operations including equipment knowledge and processes (disposable technologies, clarification, chromatography skids, TFFs, formulation processes, final fill, etc.).
Location: Durham, NC. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
About OXB OXB is a quality and innovation‑led viral vector CDMO with a mission to enable life‑changing therapies to patients worldwide. With over 30 years of experience, we collaborate with leading pharmaceutical and biotechnology companies to provide expertise in lentivirus, AAV, and adenoviral vectors from early‑stage development to commercialization.
Benefits
Competitive total rewards package.
Well‑being programs supporting mental and physical health.
Career development opportunities.
Inclusive, collaborative culture.
State‑of‑the‑art labs and manufacturing facilities.
Values: Responsible, Responsive, Resilient, Respectful.
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Responsibilities
Serve as the downstream (clarification, chromatography, TFF, sterile fill/finish) technical support for the vector manufacturing process in MSAT.
Technology Transfer Technical Leader for cross‑functional team.
Lead introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of multiple cell and gene therapy platform drug substances and products.
Lead information transfer and gap assessment for new process and method transfers.
Support MSAT and Manufacturing documentation drafting/review with a strong understanding of equipment, critical process parameters, in‑process testing, etc.
Provide guidance and lead facility fit assessments of manufacturing processes in production suites, using FMEA or similar risk‑based approaches to troubleshoot processing issues.
Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols.
Provide guidance in documentation of events and deviations during cGMP manufacturing production.
Provide guidance for process equipment onboarding.
May support other tasks as determined by management.
Qualifications
BS/MS in Engineering or related field, or Biological Science with 0‑3 years of experience in a technical engineering role or related areas.
0‑3 years of experience in pharmaceutical or biologics industry in process development or manufacturing operations.
Experience implementing special projects related to operational process improvement.
Strong leadership, relationship management, and organizational planning skills.
Ability and willingness to learn and adapt skillsets for various areas of MSAT.
Knowledge of cGMP compliance around bioprocess drug substance manufacturing.
Experience with bioprocess drug substance manufacturing process development and CGMP manufacturing.
Experience in monoclonal antibody production and purification process development is a plus.
Technical expertise in upstream/downstream operations including equipment knowledge and processes (disposable technologies, clarification, chromatography skids, TFFs, formulation processes, final fill, etc.).
Location: Durham, NC. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
About OXB OXB is a quality and innovation‑led viral vector CDMO with a mission to enable life‑changing therapies to patients worldwide. With over 30 years of experience, we collaborate with leading pharmaceutical and biotechnology companies to provide expertise in lentivirus, AAV, and adenoviral vectors from early‑stage development to commercialization.
Benefits
Competitive total rewards package.
Well‑being programs supporting mental and physical health.
Career development opportunities.
Inclusive, collaborative culture.
State‑of‑the‑art labs and manufacturing facilities.
Values: Responsible, Responsive, Resilient, Respectful.
#J-18808-Ljbffr