Director, Biologics, Cell & Gene TherapyPosition Title: Director, Biologics, Cell & Gene Therapy
Department: CMC Analytical Services
Reports To: VP / Senior Vice President of Analytical Services
Position SummaryThe 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.
