Director BGC Operations

Frontage Laboratories, Inc.; Exton, Northern (PA, KY); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Disability insurance

Life insurance

Job summary

Frontage Laboratories Inc. in Exton, PA seeks a Director, Biologics, CGT to lead technical operations, client engagement, and strategic growth within a CDMO/CRO environment.

The role oversees viral vector development, cell therapies (CAR-T, stem cells), and recombinant biologics, ensuring cGMP/GLP compliance, high-margin service delivery, and cross-functional collaboration with BD, QA, and Regulatory.

Qualifications

• Education requires Ph.D. or M.S. in biotechnology, bioengineering, molecular biology, biochemistry or related life sciences field.
• 10+ years in biopharmaceutical industry with at least 4+ years in a leadership role within CDMO/CRO.
• Strong client-facing leadership with experience managing SOWs, revenue targets, and multi-project portfolios in ATMP/CGT.

Responsibilities

• Lead high-visibility governance with external biopharma partners and act as executive contact for problem-solving and milestone delivery.
• Partner with BD to scope technical proposals, develop SOWs, evaluate feasibility, and present capabilities in client pitches and audits.
• Direct cross-functional teams through technology transfers, assay development/validation, and cGMP testing for clinical/commercial products.
• Ensure global cGMP/GLP compliance and host client audits/regulatory inspections.

Skills

Client-Facing Leadership

Technical Breadth

Strategic Leadership

Education

Ph.D./M.S. in Biotechnology or related life sciences

Job description

Director BGC Operations

Full Time Exton, PA, US

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.