Process Engineer II - Biologics GMP & 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

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.