OXB · 23 hours ago
Process Engineer I/II (MSAT)
Durham, NC
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expOXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. The Process Engineer II will lead the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing, playing a key part in advancing the company's mission.
BiotechnologyGeneticsTherapeutics
No H1B
Responsibilities
Serve as the Downstream (clarification, chromatography, TFF, sterile fill/finish) technical support for the vector manufacturing process in MSAT Team
Technology Transfer Technical Leader for cross functional team
Leads the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of multiple cell and gene therapy platform drug substances and products
Leads the information transfer and gap assessment of new processes and method transfers
Support MSAT and Manufacturing documentation drafting/review with a strong understanding of equipment, critical process parameters, in-process testing, etc
Provides guidance and leads facility fit assessments of manufacturing processes in production suites and uses 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
Provides guidance in the documentation of events and deviations during cGMP manufacturing production
Provides guidance for process equipment on-boarding
May support other tasks as determined by management
Qualification
Required
BS/MS in Engineering or a related field or Biological Science or related field with 0-3 years of experience in a technical engineering role or related areas (or a combination of education and experience)
Requires 0-3 years of experience in pharmaceutical or biologics industry in process development or manufacturing operations
Experience in implementing special project(s) related to operational process improvement
Strong leadership, relationship management, and organizational planning
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
Technical expertise in upstream / downstream operations including equipment knowledge and processes, including but not limited to disposable technologies, clarification, chromatography skids, TFFs, formulation processes, final fill, etc
Preferred
Experience in monoclonal antibody production and purification process development is a plus
Benefits
Competitive total reward packages
Wellbeing programs that support your mental and physical health
Career development opportunities to help you grow and thrive
Supportive, inclusive, and collaborative culture
State-of-the-art labs and manufacturing facilities
Company
OXB
OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
2026-01-16
Company data provided by crunchbase