A Research Scientist is responsible for designing, undertaking and analyzing information from controlled laboratory-based investigations, experiments and trials.
Senior Scientist, Discovery & Translational Research | Durham, NC | Onsite Opus Genetics is seeking a Scientist or Senior Scientist to establish and execute an internal research-grade AAV manufacturing capability in support of discovery and translational gene therapy programs. This is a highly hands-on individual contributor role responsible for the end-to-end production, purification, characterization, and release of research-grade AAV vectors at scales up to 1 liter. The successful candidate will be expected to act independently in executing each phase of the workflow while drawing on scientific and operational support from other members of the Discovery & Translational Medicine research group. The ideal candidate will bring significant practical experience in AAV production and process development, with the ability to establish grade-appropriate operating procedures, generate high-quality vector material for research studies, and collaborate effectively with Research, Translational Medicine, Analytical Development, and CMC colleagues.
Duties/Responsibilities:
Research-Grade AAV Production Independently execute all phases of high-quality research-grade AAV manufacturing, from plasmid preparation through vector harvest, purification, characterization, and release to support discovery, translational, and preclinical research activities. Perform upstream activities up to 1 liter scale including mammalian cell culture, routine mycoplasma testing, transient transfection, harvest, residual DNA removal and clarification. Perform downstream purification using fit-for-purpose methods such as tangential flow filtration, affinity chromatography, buffer exchange, and formulation. Perform core AAV release assays, including vector genome titer determination by qPCR/ddPCR, capsid purity assessment by SDS-PAGE, and endotoxin testing. Troubleshoot production and purification challenges and implement practical improvements to enhance yield, purity, reproducibility, and operational efficiency. Process Establishment and Laboratory Operations Build and optimize internal research-grade AAV production workflow using prior industry experience and scientific judgment. Identify and implement appropriate equipment, reagents, consumables, controls, analytical methods, and documentation practices required to support internal vector production. Write and maintain grade-appropriate operating procedures, batch worksheets, run records, checklists, and laboratory workflows suitable for research-stage manufacturing activities. Establish practical controls to support consistency, traceability, sample tracking, material disposition, and data integrity. Maintain an organized, compliant, and safe laboratory environment appropriate for gene therapy research. Cross-Functional Collaboration Partner closely with Discovery and Translational Medicine scientists to understand program-specific vector needs, timelines, and experimental objectives. Collaborate with Analytical Development and CMC colleagues to ensure research-stage manufacturing practices and data packages remain aligned with future development needs. Provide technical input regarding vector manufacturability, process performance, product quality attributes, and release considerations during project team discussions. Support technical interactions with external testing laboratories when specialized analytical support is required.
Required Qualifications and Skills:
B.S. or M.S. in Molecular Biology, Cell Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, Virology, Gene Therapy, or a related scientific discipline. 5 or more years of relevant industry experience in AAV manufacturing, process development, vector core operations, gene therapy research, or related fields. Demonstrated experience independently producing, purifying, characterizing, and releasing research-grade AAV vectors on demand and on time. Hands-on expertise with mammalian cell culture, transient transfection, upstream processing, downstream purification, formulation, and analytical characterization of AAV vectors. Strong understanding of AAV Certificates of Analysis and critical quality attributes, including genome titer, purity, endotoxin, sterility, mycoplasma, residual impurities, and capsid-related characteristics. Experience coordinating outsourced analytical testing, including empty/full capsid analysis and other specialized characterization assays, and integrating those results into lot release decisions. Ability to troubleshoot manufacturing processes, analytical methods, and unexpected product quality results to identify root causes and implement corrective actions. Experience establishing practical laboratory workflows, batch records, and grade-appropriate operating procedures suitable for research-stage manufacturing. Strong experimental design, data interpretation, technical writing, organizational, and communication skills. Ability to work independently as the primary hands-on contributor while collaborating effectively with Discovery & Translational Medicine, Analytical Development, and CMC colleagues. Experience working in a small-company, startup, or highly collaborative research environment where independent execution and process development are expected.
Location:
Durham, NC Salary Range:
$140,000-160,000 The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Pay:
$140,000.00•$160,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance Application Question(s): Are you able to commute to this job's location in Durham, NC Monday•Friday or planning to relocate if hired? Does our budgeted salary of $140K•$160K meet your salary requirements? (Final offer will be dependent upon relevant experience level) In your own words, please describe your experience in AAV manufacturing and release.
