Biotechnology company is hiring a Principal Scientist to join the Process Development team. You will be responsible for leading late-stage upstream process development for adeno-associated virus (AAV) gene therapy programs. The successful candidate will drive the design, optimization, and scale-up of upstream processes to support clinical and commercial manufacturing. This role requires a deep understanding of cell culture, bioreactor and AMBR systems, and gene therapy-specific challenges in AAV vector production, as well as experience in transitioning processes to GMP-compliant manufacturing.
Responsibilities
- Lead the late-stage development and optimization of upstream processes for AAV production, ensuring scalability, reproducibility, and compliance with regulatory standards.
- Design and execute experiments to optimize cell culture conditions, transfection parameters, and bioreactor performance.
- Develop scalable upstream processes compatible with GMP requirements, including suspension cell culture systems.
- Collaborate with cross-functional teams in analytical development, downstream processing, quality control, and regulatory affairs to ensure seamless transition from development to production.
- Provide technical expertise in troubleshooting and resolving upstream process issues, working closely with manufacturing teams.
- Support process characterization/validation studies (including FMEA, scale-down model establishment and DOE/OFAT approach to identify critical process parameters) and process performance qualification, including review of development, manufacturing, process characterization and validation protocols and reports.
- Support the development and implementation of an (upstream and downstream) process monitoring/control strategy program using appropriate statistical guidelines.
- Author and review technical documents, including development reports, SOPs, and CMC sections for regulatory filings.
- Stay updated on industry trends and emerging technologies in gene therapy manufacturing to maintain best-in-class process development practices.
- Manage internal lab operations and lead direct reports.
Qualifications
- Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or related field with 6+ years of relevant experience in upstream process development; or M.S. with 8+ years of experience.
- Proven experience in AAV or other viral vector production, particularly in late-stage development for clinical/commercial scale manufacturing.
- Strong expertise in cell culture, bioreactor design and operation, and viral vector transfection techniques.
- Experience with scalable, single-use bioreactor and AMBR systems.
- Knowledge of GMP requirements and regulatory guidelines for gene therapy products.
- Must-have advanced knowledge of DOE principles, process characterization, and BLA enabling activities.
- Background in authoring sections of regulatory submissions, including IND, or BLA filings.
- Excellent problem-solving skills with the ability to troubleshoot and optimize complex bioprocesses.
- Strong communication and leadership skills to manage cross-functional projects and mentor team members.
Salary
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.