The Manager, Upstream Process Development is responsible for leading a team of scientists and engineers focused on the development, optimization, characterization, and scale-up of upstream processes for AAV and other viral vector gene therapy products. This role provides scientific and technical leadership across process development activities from early-stage development through commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. The successful candidate will collaborate cross-functionally with Manufacturing, MS&T, Analytical Development, Quality, Regulatory Affairs, and Supply Chain teams to deliver development milestones and support successful technology transfer and commercialization.
- Lead the design, development, optimization, and scale-up of upstream manufacturing processes, including cell culture, media development, seed train expansion, and bioreactor operations.
- Establish scientifically sound process development strategies to enhance productivity, product quality, process robustness, and manufacturing efficiency.
- Lead process characterization studies, risk assessments, and design of experiments (DoE) activities.
- Provide technical oversight for process troubleshooting, investigations, and continuous improvement initiatives.
Evaluate and implement innovative technologies and platform process approaches to improve development timelines and manufacturing performance.
Education | Experience | Certifications or Licenses:- Minimum BS degree in biochemical engineering, chemical engineering, biology, biochemistry, biotechnology, or a related discipline required; MS or PhD preferred.
- 7+ years (BS), 5+ years (MS), or 3+ years (PhD) of relevant upstream process development or manufacturing experience in biologics, viral vectors, or gene therapy.
- 3+ years of hands-on AAV or viral vector production experience in suspension at different scales including shake flask and bioreactors.
- Experience supporting cGMP manufacturing, technology transfer, and IND or clinical-stage programs required.
Knowledge | Skills | Abilities:- Deep technical knowledge of AAV or viral vector upstream operations, including suspension mammalian cell culture and cell growth optimization, shake flask optimization, and suspension bioreactor expertise.
- Experience developing scalable production processes and applying scale-down models, DOE, process characterization, and risk-based development principles.
- Proficiency in operating and troubleshooting suspension bioreactor systems (Sartorius and Eppendorf) and interpretation of common process and product-quality data.
- Working knowledge of critical quality attributes, critical process parameters, process performance metrics, and data-driven troubleshooting.
- Working knowledge of cGMP principles, data integrity, phase-appropriate documentation, deviations, change control, and CAPA or investigation support.
- Ability to author and review protocols, development reports, process flow diagrams, SOPs, batch records, risk assessments, and technology transfer documents.
- Excellent technical writing, communication, project leadership, and collaboration skills; able to communicate effectively with internal teams, clients, and CDMO partners.
- Ability to mentor junior staff and work independently in a fast-paced, multi-project environment.
- Leadership experience managing scientific teams and complex development projects.
Travel:- Ability to travel domestically up to 10% of the time to support client, CDMO, training, or project needs.
On-Site:- This is a hands-on laboratory-based role requiring full-time on-site presence at the King of Prussia Discovery Labs location.
Immunizations and Screenings:- This position requires access to laboratory spaces and the ability to work safely with biological materials, chemicals, and required personal protective equipment.
Essential Status:- Essential for Research: May be required to work on-site during periods of adjusted operations to support time-sensitive research, biological materials, and critical development activities.
Vision:Ability to distinguish between different colors, read technical documents and laboratory equipment, and maintain visual concentration for extended periods.
