Senior Scientist III, Downstream Process Deve at Franklin Bio Lab

King of Prussia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

0.0

Posted On

27 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Downstream Process Development, AAV Purification, Chromatography, Tangential Flow Filtration, Quality by Design, Scale-up, Technology Transfer, cGMP, Process Characterization, DOE, Technical Writing, Project Leadership

Industry

Biotechnology Research

Description

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. Job Description 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. * 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. 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 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. Knowledge | Skills | Abilities: * 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. 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. Company 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)

Responsibilities

Lead the development, optimization, and scale-up of downstream purification processes for AAV and viral vector gene therapy products. Partner with cross-functional teams to deliver robust, phase-appropriate processes from early development through clinical manufacturing.