Executive Director, Molecular Bioanalysis

Franklin Bio Lab•King of Prussia, PA

14d•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. Franklin Biolabs, Inc. is in search of an Executive Director, Molecular Bioanalysis who will serve as a visionary and experienced leader within our Bioanalytics business unit, reporting directly to the SVP, Head of Operations. This role is responsible for designing, overseeing, and interpreting bioanalytical strategies to support pharmacokinetics (PK), pharmacodynamics (PD), biodistribution, shedding, and biomarker analyses in compliance with global regulatory expectations. The ideal candidate will bring deep expertise in bioanalysis to support cell, gene and RNA based therapies, to elevate our team’s capabilities and position Franklin Biolabs as a leader in preclinical and clinical bioanalysis. The candidate must have deep hands-on experience with multiple bioanalytical platforms, including qPCR/ddPCR, LC-MS/MS, ELISA, MSD, and flow cytometry. Primary Responsibilities will include: Strategic leadership of the Molecular Bioanalysis team, including defining and executing bioanalytical strategies for RNA therapeutics, gene therapies (viral and non-viral), and cell-based therapies across all stages of development. Serve as a subject-matter expert for bioanalysis, advising development teams on assay selection, study design, and data interpretation, including contributing to the overall development strategy, and phase-appropriate development to support IND/CTA-enabling studies and late-stage clinical programs. Team Management and Development: Build, mentor, and lead a high-performing team of scientists and analysts, fostering a culture of collaboration, continuous improvement, and excellence in GxP and non-GLP environments. Technical Oversight: Provide expert guidance on bioanalytical methodologies, including immunogenicity testing, pharmacokinetics, biodistribution, and biomarker assays. Ensure robust application of in vitro and in vivo techniques, with a strong emphasis on LNP characterization, stability, and immune response evaluation in preclinical models. Client Collaboration and Business Development: Serve as a key technical liaison for biotech, pharma, and academic clients, ensuring clear communication, customized solutions, and successful project delivery. Contribute to business development by identifying client needs and promoting our integrated services. Identify opportunities to enhance service offerings, incorporate cutting-edge technologies, and enhance productivity to support the achievement of revenue targets for this team. Quality and Compliance: Maintain the highest standards of quality, regulatory compliance (e.g., FDA, EMA guidelines), and data integrity in all bioanalytical operations. Innovation and Integration: Collaborate across business units to integrate bioanalytics with pharmacology/toxicology, vector manufacturing, and analytics, driving efficiencies and innovative approaches for advanced therapies. Resource Management: Oversee budgeting, resource allocation, and facility utilization to support scalable growth in a startup environment.

Requirements

PhD in Bioanalytical Chemistry, Pharmacology, Molecular Biology, Biochemistry, or related discipline (required) Minimum of 10 years of progressive experience in bioanalytics, with at least 5 years in a leadership role within a preclinical CRO environment.
Proven expertise with gene, and RNA therapies.
Strong understanding of cell and gene therapy, preclinical research, and regulatory pathways (e.g., IND processes); familiarity with GLP studies, vector services, and bioanalytics is a plus.
Self-starter with strong project management skills, able to thrive in a collaborative, entrepreneurial setting while managing multiple competing priorities and deadlines.
Ability to communicate clearly and effectively, both verbally and in writing, to interact with team members, clients, vendors and other third parties.
Ability to simplify complex scientific concepts for diverse audiences.
Ability to collaborate effectively with individuals across various disciplines to ensure alignment.
Ability to use digital communication tools (video conferencing, chat platforms etc.) to effectively collaborate with team members in hybrid and remote settings.
Ability to travel domestically and/or internationally up to 10% of the time, depending on the needs of the project, the client and the company. Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.
This position requires full-time on-site presence at our Discovery Labs location in King of Prussia, Pennsylvania.
This position requires access to lab and lab animal spaces.
Ability to distinguish between different colors (normal color vision).
Ability to see clearly at various distances.
Adequate near vision for reading documents or lab equipment.
Ability to focus and maintain concentration in tasks for extended periods.
Ability to work in environments with varying light conditions.

Responsibilities

Strategic leadership of the Molecular Bioanalysis team, including defining and executing bioanalytical strategies for RNA therapeutics, gene therapies (viral and non-viral), and cell-based therapies across all stages of development.
Serve as a subject-matter expert for bioanalysis, advising development teams on assay selection, study design, and data interpretation, including contributing to the overall development strategy, and phase-appropriate development to support IND/CTA-enabling studies and late-stage clinical programs.
Team Management and Development: Build, mentor, and lead a high-performing team of scientists and analysts, fostering a culture of collaboration, continuous improvement, and excellence in GxP and non-GLP environments.
Technical Oversight: Provide expert guidance on bioanalytical methodologies, including immunogenicity testing, pharmacokinetics, biodistribution, and biomarker assays. Ensure robust application of in vitro and in vivo techniques, with a strong emphasis on LNP characterization, stability, and immune response evaluation in preclinical models.
Client Collaboration and Business Development: Serve as a key technical liaison for biotech, pharma, and academic clients, ensuring clear communication, customized solutions, and successful project delivery. Contribute to business development by identifying client needs and promoting our integrated services. Identify opportunities to enhance service offerings, incorporate cutting-edge technologies, and enhance productivity to support the achievement of revenue targets for this team.
Quality and Compliance: Maintain the highest standards of quality, regulatory compliance (e.g., FDA, EMA guidelines), and data integrity in all bioanalytical operations.
Innovation and Integration: Collaborate across business units to integrate bioanalytics with pharmacology/toxicology, vector manufacturing, and analytics, driving efficiencies and innovative approaches for advanced therapies.
Resource Management: Oversee budgeting, resource allocation, and facility utilization to support scalable growth in a startup environment.