Senior Process Scientist, MSAT (Durham)
About Opus Genetics 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. Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Education: Master's (Preferred) Work Location: Hybrid remote in Durham, NC 27712
