Director

Frontage Laboratories, Inc; Exton (PA); On-site; USD 220,000 - 300,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Disability insurance

Life insurance

Job summary

Frontage Laboratories Inc. is seeking a Director of Biologics, Cell & Gene Therapy to lead technical operations, business growth, and service delivery for CGT programs.

You will serve as the executive contact for client partners, ensuring scientific excellence, regulatory compliance, and high-throughput operations across viral vectors, cell therapies, and recombinant biologics. The role requires senior leadership in a CDMO/CRO environment with deep process/analytical development and regulatory

Qualifications

• Education: Ph.D. or M.S. in Biotechnology, Bioengineering, Molecular Biology, Biochemistry, or related life sciences field.
• Experience: 10+ years in biopharmaceutical industry with minimum 4+ years in leadership within a CDMO/CRO/contract testing organization.
• Client-Facing Leadership: Demonstrated success managing client relationships, SOW scope, revenue targets, and multi-project portfolios in ATMP/CGT.
• Technical breadth: Deep knowledge of process/analytical development, vector biomanufacturing, cell processing, and regulatory expectations for ATMP contracts.

Responsibilities

• Lead client engagements and governance, acting as executive contact for problem-solving and milestone delivery.
• Partner with BD to scope technical proposals, create SOWs, assess feasibility, and present capabilities in client meetings and audits.
• Direct cross-functional teams in tech transfer, analytical development/validation, and cGMP testing for clinical/commercial products.
• Ensure compliance with global cGMP/GLP regulations and host client audits and regulatory inspections.

Skills

Client-facing leadership

Regulatory knowledge

Process/analytical development

Bioprocess manufacturing

Education

Ph.D. or M.S. in Biotechnology/Bioengineering/Molecular Biology/Biochemistry

Job description

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.