Manager, Upstream Process Development

Franklin Bio Lab • King of Prussia, PA

7h • Onsite

About The Position

Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.

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.

Requirements

• 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.
• 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.
• Ability to travel domestically up to 10% of the time to support client, CDMO, training, or project needs.
• This is a hands-on laboratory-based role requiring full-time on-site presence at the King of Prussia Discovery Labs location.
• This position requires access to laboratory spaces and the ability to work safely with biological materials, chemicals, and required personal protective equipment.
• May be required to work on-site during periods of adjusted operations to support time-sensitive research, biological materials, and critical development activities.
• Ability to distinguish between different colors, read technical documents and laboratory equipment, and maintain visual concentration for extended periods.

Nice To Haves

• MS or PhD preferred.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager