Process Engineer I/II (MSAT)

Oxfordbiom; Durham (NC); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Competitive rewards

Wellbeing programs

Career development

Collaborative culture

State-of-the-art labs

Job summary

Oxfordbiom in Durham, NC, is seeking a Process Engineer II to lead transfer of new manufacturing processes for clinical and commercial use within our MSAT team.

You will provide upstream (cell culture) technical support, draft technical documents, support risk assessments, and drive process improvements. Expect 24/7 support and ~10% travel to support cross-functional activities with Manufacturing, Engineering, Quality, and Supply Chain.

Qualifications

• BS/MS in Engineering, Biological Sciences, or related field.
• Minimum 3 years' experience in biologics/pharma GMP manufacturing.
• Strong understanding of bioprocess operations and equipment.
• Ability to author/review GMP documents (SOPs, batch records).
• Willingness for 24/7 operations and ~10% travel.
• Experience with cell or gene therapy manufacturing is a plus.

Responsibilities

• Provide upstream (cell culture) technical support in GMP manufacturing.
• Lead tech transfers and cross-functional activities; own assigned workstreams.
• Draft/review tech transfer plans, protocols, impact assessments, and change actions.
• Support facility fit, troubleshooting, risk assessments (FMEA).
• Drive process improvements for compliant manufacturing.
• Collaborate with Manufacturing, Engineering, Quality, Process Development, and Supply Chain.
• Assist materials assessments and BOM alignment for technical accuracy.

Skills

Upstream bioprocess ops

GMP manufacturing

SOPs/batch records

Cross-functional collaboration

Problem solving

Education

BS/MS in Engineering or Biological Sciences

Tools

JMP

Skyland Analytics

Job description

Join Us in Changing Lives

At OXB , our people are at the heart of everything we do.

We're on a mission to enable life-changing therapies to reach patients around the world---and we're looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us.

We're currently recruiting for a Process Engineer II to join our MSATteam. In this role, you will be responsible for leading the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Provide Upstream (cell culture) technical support (cell expansion, 50 -- 500 L bioreactors, and transfection) in a GMP manufacturing environment
• Contribute significantly to technology transfers, process introductions and cross-functional activities, taking ownership of assigned workstreams as appropriate.
• Draft and review technical documentation---tech transfer plans, protocols, impact assessments, change actions, process descriptions, and reports.
• Support facility fit, process troubleshooting, gap analysis and risk assessments (FMEA).
• Drive process improvements to enable efficient, compliant manufacturing.
• Closely collaborate with cross-functional groups including Manufacturing, Engineering, Quality, Process Development and Supply Chain.
• Support raw material assessments by understanding material criticality, specifications, supplier or lot variability, GMP controls, and potential process impact.
• Support BOM alignment by reviewing raw materials, consumables, quantities, specifications, and process-use points to ensure technical accuracy and manufacturing readiness.

We are Looking For:

• BS/MS in Engineering, Biological Sciences, or related field.
• Minimum 3 years' experience in biologics or pharmaceutical manufacturing (GMP environment).
• Strong understanding of bioprocess operations and equipment.
• Excellent problem-solving, teamwork, organization and communication skills.
• Demonstrated ability to author, review, and adhere to SOPs, batch records, and controlled documents in accordance with GMP requirements.
• Flexibility to support 24/7 operations and occasional travel (~10%).
• Experience with cell or gene therapy manufacturing.
• Familiarity with FDA/EU GMP standards.
• Knowledge of data/statistical software (e.g., JMP, Skyland Analytics).

The following additional skill(s) are desirable:

• Knowledge of downstream processing operations and/or DP.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

About Us:

OXB 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. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies.

OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Why Join Us?

• 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
• A company that lives its values Responsible, Responsive, Resilient, Respect

Ready to Make a Difference?