MSAT Process Lead, AAV Gene Therapy (Hybrid)

Opus Genetics; Durham (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

Vision insurance

Job summary

Opus Genetics, a Durham, NC-based biotech company, seeks a Process Scientist, MSAT to lead day-to-day manufacturing for AAV gene therapy programs. You will oversee batch records, deviations, and CAPAs, and collaborate with CDMOs and internal teams in a cross-functional setting.

You will support PPQ activities, process validation, tech transfers, and lifecycle management, while driving process improvements and regulatory readiness. Hybrid/remote options may be considered.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Molecular Biology, Biochemistry, or related discipline.
• Minimum of 4 years in hands-on process development, MSAT, manufacturing sciences, or CMC in biotech/pharma.
• Experience supporting AAV gene therapy manufacturing and GMP production activities.
• Experience reviewing batch records and supporting deviations, investigations, and CAPA.
• Hands-on experience with process validation, PPQ, and continued process verification.

Responsibilities

• Serve as day-to-day manufacturing lead for assigned AAV programs, including starting materials.
• Review batch records and manufacturing docs for accuracy, GMP compliance, and technical correctness.
• Act as primary process representative during CDMO campaigns (in-plant).
• Investigate deviations, nonconformances, CAPA activities and root cause analysis.
• Support PPQ activities: protocol review, risk assessment, data analysis, reporting.
• Monitor manufacturing performance and identify improvement opportunities and risks.
• Prepare and review technical/regulatory documents and summaries.
• Support tech transfer between development, manufacturing, and external partners.
• Contribute to process characterization, validation, and lifecycle management.
• Lead device compatibility studies at Durham labs.
• Collaborate across Analytical Development, Quality, Regulatory, Supply Chain, and Manufacturing.

Skills

Process development

MSAT

GMP oversight

Batch records review

Deviation investigation

Regulatory support

Cross-functional collaboration

Technical writing

CDMO collaboration

Biotech/pharma experience

Education

Master's or Bachelor's in Chemical/Biochemical Engineering or related

Experience in biotechnology/gene therapy fields

Job description

Opus Genetics, a Durham, NC-based biotech company, seeks a Process Scientist, MSAT to lead day-to-day manufacturing for AAV gene therapy programs. You will oversee batch records, deviations, and CAPAs, and collaborate with CDMOs and internal teams in a cross-functional setting.

You will support PPQ activities, process validation, tech transfers, and lifecycle management, while driving process improvements and regulatory readiness. Hybrid/remote options may be considered.