Director, Biologics, Cell & Gene Therapy
Position Title: Director, Biologics, Cell & Gene Therapy
Department: CMC Analytical Services
Reports To: VP / Senior Vice President of Analytical Services
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, Europe, and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary
The Director of Biologics, Cell & Gene Therapy (CGT) serves as a senior executive leader within our Contract Development and Manufacturing Organization (CDMO) / Contract Research Organization (CRO). This client-facing role is responsible for directing technical operations, business growth, and service delivery. The Director acts as the primary executive contact for client partners, ensuring technical excellence, regulatory compliance, operational throughput, and high-margin service execution across viral vectors (AAV, LVV), cell therapies (CAR-T, stem cells), and recombinant biologics platforms.
Key Responsibilities
- Client Engagement & Service Delivery: Lead high-visibility technical governance with external biopharma partners, acting as the executive point of contact for technical problem-solving, project scope adjustments, and milestone delivery.
- Business Development & Proposal Support: Partner with BD teams to scope technical proposals, develop Statements of Work (SOWs), evaluate technical feasibility, and present capabilities in client pitch meetings and facility audits.
- CMC & Tech Transfer Execution: Direct cross-functional scientific teams through client technology transfers, analytical assay development/validation, and cGMP clinical/commercial product testing.
- Quality & Regulatory Compliance: Ensure full adherence to global cGMP/GLP regulations (FDA, EMA) during client manufacturing and analytical testing; host client audits and regulatory inspections.
Required Qualifications & Experience
- Education: Ph.D. or M.S. in Biotechnology, Bioengineering, Molecular Biology, Biochemistry, or related life sciences field.
- Experience: 10+ years in the biopharmaceutical industry with a minimum of 4+ years in a leadership role directly within a CDMO, CRO, or contract testing organization.
- Client-Facing Leadership: Demonstrated success managing client relationships, SOW scope management, revenue targets, and multi-project service portfolios in the ATMP/CGT sector.
- Technical Breadth: Deep knowledge of process/analytical development, vector biomanufacturing, cell processing, and regulatory expectations for advanced therapy contract services.
Salary and Benefits:
Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Ph.D. or M.S. in Biotechnology, Bioengineering, Molecular Biology, Biochemistry, or a related life sciences field
- 10+ years of experience in the biopharmaceutical industry
- At least 4 years of leadership experience within a CDMO, CRO, or contract testing organization
- Demonstrated success managing client relationships, SOW scope, revenue targets, and multi-project service portfolios in the ATMP/CGT sector
- Deep knowledge of process and analytical development, vector biomanufacturing, cell processing, and regulatory expectations for advanced therapy contract services
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
