Senior Scientist III, Downstream Process Deve
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 therapies. 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 Senior Scientist III, Downstream Process Development is responsible for leading the development, optimization, characterization, scale-up, and transfer of downstream purification processes for AAV and other viral vector gene therapy products. This hands-on technical leader partners with cross-functional teams to deliver scalable, robust, and phase-appropriate processes from early development through clinical manufacturing.
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 downstream process development or manufacturing experience in biologics, viral vectors, or gene therapy.
- 3+ years of hands-on AAV or viral vector downstream purification experience, including chromatography and tangential flow filtration, required.
- Experience supporting cGMP manufacturing, technology transfer, and IND or clinical-stage programs required.
- Deep technical knowledge of AAV or viral vector downstream operations, including clarification, affinity capture, ion exchange chromatography, TFF, formulation, and sterile filtration.
- Experience developing scalable purification processes and applying scale-down models, DOE, process characterization, and risk-based development principles.
- Proficiency with chromatography skids and columns, TFF systems, filtration devices, 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.
- Ability to distinguish between different colors, read technical documents and laboratory equipment, and maintain visual concentration for extended periods.
Responsibilities
- Lead development, optimization, characterization, and scale-up of downstream purification processes for viral vector gene therapy products.
- Apply QbD and data-driven approaches to establish robust, scalable, and phase-appropriate unit operations.
- Serve as a downstream subject matter expert for technical troubleshooting, manufacturing support, and technology transfer.
Benefits
- 401(k)
- 401(k) Matching
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account and Flexible Spending Account
- Paid Time-Off
- Company Paid Holidays
- Personal Floating Holidays
- Short-Term and Long-Term Disability
- Life and AD&D insurance (Group & Voluntary)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
