Senior Process Scientist, MSAT

Opus Genetics; Durham (NC); Híbrido; USD 120 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k)

Health insurance

Paid time off

Vision insurance

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Process development

MSAT

GMP oversight

Batch records review

Deviation investigation

Regulatory support

Cross-functional collaboration

Technical writing

CDMO collaboration

Biotech/pharma experience

Formação académica

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

Experience in biotechnology/gene therapy fields

Descrição da oferta de emprego

Opus Genetics is a clinical-stage biotechnology company developing transformational gene therapies for patients with inherited retinal diseases. Based in Durham, NC, we combine cutting-edge science with a patient-first mission - and we're building the team to take our programs from bench to bedside.

The Role

The Process Scientist, MSAT will be a core member of the CMC team, responsible for the day-to-day execution and oversight of manufacturing activities for Opus Genetics' AAV-based gene therapy programs. You'll serve as Opus's primary process subject matter expert - working directly with CDMOs, reviewing batch records, investigating deviations, and driving process validation and PPQ activities. This is a highly cross-functional role working hands on with process development, manufacturing operations, and regulatory support.

This role is based in the Research Triangle Park (RTP), NC area, with 10–25% travel to manufacturing partner locations. Hybrid/remote options may be considered based on candidate background and experience.

What You'll Do

• Serve as the day-to-day manufacturing lead for assigned AAV gene therapy programs, including critical starting materials (plasmids and HEK293 cell banks)
• Review batch production records and manufacturing documentation for accuracy, GMP compliance, and technical correctness
• Act as Opus' primary process representative during manufacturing campaigns at CDMOs (person in plant)
• Investigate process deviations, nonconformances, and manufacturing issues; lead root cause analysis and CAPA activities
• Support Process Performance Qualification PPQ activities - protocol and risk assessment review, execution, data analysis, and reporting
• Monitor manufacturing performance and trends to identify improvement opportunities and risks
• Author and review technical reports, comparability assessments, manufacturing summaries, and regulatory support documents
• Support technology transfer between development, manufacturing, and external partners
• Contribute to process characterization, validation, and lifecycle management
• Lead device compatibility studies at our Durham labs
• Collaborate across Analytical Development, Quality, Regulatory, Supply Chain, and Manufacturing

What We're Looking For

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Molecular Biology, Biochemistry, or a related scientific discipline.
• Minimum of 4 years of experience in hands-on process development, manufacturing sciences (MSAT), manufacturing support, or other CMC functions within the biotechnology, pharmaceutical, biologics, or gene therapy industries.
• Experience supporting AAV gene therapy manufacturing, including viral vector upstream and/or downstream manufacturing processes.
• Experience supporting manufacturing operations, process transfers, and clinical- or commercial-stage GMP production activities.
• Experience reviewing batch records and manufacturing documentation and supporting manufacturing deviations, investigations, and CAPA activities.
• Hands-on experience of process validation, Process Performance Qualification (PPQ), and continued process verification principles. Supporting BLA/marketing application preparation will be a plus.
• Experience working with CDMOs and external manufacturing partners.
• Strong understanding of GMP regulations and regulatory requirements, including FDA, EMA, ICH, and other applicable industry standards.
• Strong technical writing, problem-solving, organizational, and communication skills, with the ability to manage multiple priorities while collaborating across cross-functional teams.
• Proven experience in a small‑to mid‑sized biopharma environment

Nice to Have Skills and Experience

• Ophthalmology and/or rare/ultra-rare disease experience
• BLA or marketing application filing support
• Startup mindset - flexible, resourceful, and comfortable building in ambiguity

Travel:

10–25% to CDMO and manufacturing partner sites

Opus Genetics is an equal opportunity employer. We do not discriminate on the basis of race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected under applicable law.

• 401(k)
• Health insurance
• Paid time off
• Vision insurance

Education:

• Master's (Preferred)