Principal Scientist (Upstream Process Development)

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.ResponsibilitiesLead 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.QualificationsPh.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$160K-$185KR&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.

Created: 2025-01-09