What are the responsibilities and job description for the Principal Scientist (Upstream Process Development) position at R&D Partners?
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
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.
Salary : $160,000 - $185,000
