Role Overview for Director-to-VP Fill-Finish Manufacturing with a Pharmaceutical Company Jacksonville, FL
JRG Partners is proud to partner with a leading, innovation-driven pharmaceutical company in their search for a visionary and experienced Director-to-VP of Fill-Finish Manufacturing. This is a pivotal senior leadership position based at their state-of-the-art manufacturing facility in Jacksonville, Florida. The successful candidate will assume ultimate responsibility for the strategic direction, operational excellence, and regulatory compliance of all sterile drug product manufacturing operations.
This executive role is critical to the company’s mission of delivering life-saving and life-changing therapies to patients worldwide. You will be at the helm of a large, multi-faceted department responsible for the aseptic filling, lyophilization, and finishing of a diverse portfolio of biologic and small molecule products, spanning late-stage clinical development through to large-scale commercial supply. The scope of this role is significant, requiring a leader who can balance day-to-day operational demands with long-term strategic planning, technological innovation, and robust team development.
As the Director/VP, you will be the primary site leader for all fill-finish activities, ensuring that every unit produced meets the highest standards of quality, safety, and efficacy. You will cultivate a culture of continuous improvement, operational discipline, and unwavering compliance with global regulatory standards. This position offers a unique opportunity to make a substantial impact on the organization’s growth trajectory, drive the adoption of cutting-edge manufacturing technologies, and lead a talented team of professionals dedicated to manufacturing excellence. We are seeking a strategic thinker with a deep technical understanding of aseptic processing and a proven track record of leadership in a cGMP environment.
Key Responsibilities of Director-to-VP Fill-Finish Manufacturing with a Pharmaceutical Company Jacksonville, FL
The Director/VP of Fill-Finish Manufacturing will have a broad range of responsibilities, including but not limited to:
Strategic & Operational Leadership
- Develop and execute the long-term strategic vision for the Fill-Finish Manufacturing department, aligning with overall company objectives and growth plans.
- Provide dynamic leadership and oversight for all aseptic manufacturing operations, including formulation, vial and syringe filling, lyophilization, capping, and visual inspection.
- Ensure the achievement of production targets related to safety, quality, output, and cost, while maintaining the highest levels of cGMP compliance.
- Drive operational excellence initiatives using Lean, Six Sigma, and other continuous improvement methodologies to enhance efficiency, reduce waste, and optimize workflows.
- Lead capacity planning and resource allocation to meet clinical and commercial demand forecasts, including planning for new product introductions and technology transfers.
- Champion the evaluation and implementation of new manufacturing technologies, such as robotics, automation, and advanced process analytical technology (PAT), to improve quality and efficiency.
Quality & Regulatory Compliance
- Serve as the ultimate authority for ensuring the department operates in strict compliance with all applicable Current Good Manufacturing Practice (cGMP) regulations and guidelines from global health authorities (e.g., FDA, EMA, PMDA).
- Act as the primary subject matter expert and host for regulatory inspections and client audits of the fill-finish manufacturing areas.
- Oversee the robust execution of deviation investigations, root cause analysis (RCA), and the implementation of effective Corrective and Preventive Actions (CAPAs).
- Ensure all manufacturing processes, equipment, and facilities are maintained in a validated state. Review and approve key validation documents, batch records, and SOPs.
- Foster a ‘quality-first’ culture where every team member understands and is accountable for their role in patient safety and product quality.
Team Management & Development
- Lead, mentor, and develop a high-performing manufacturing leadership team, fostering a collaborative and results-oriented environment.
- Establish departmental goals and objectives, monitor performance through key performance indicators (KPIs), and provide regular feedback and coaching.
- Champion talent development, succession planning, and training programs to ensure the organization has the skills and leadership pipeline needed for future growth.
- Promote a strong safety culture, ensuring all operations are conducted in compliance with Environmental, Health, and Safety (EHS) policies and procedures.
Financial & Cross-Functional Collaboration
- Develop and manage the annual operating budget and capital expenditure plan for the Fill-Finish department.
- Identify and implement cost-saving initiatives without compromising quality or compliance.
- Collaborate effectively with other key functions, including Quality Assurance, Quality Control, Engineering, Supply Chain, Process Development, and Regulatory Affairs, to ensure seamless operations and successful product lifecycle management.
- Represent Manufacturing on site leadership teams and global project teams, providing critical input and ensuring alignment across the organization.
Requirements for the Director-to-VP Fill-Finish Manufacturing with a Pharmaceutical Company Jacksonville, FL
The ideal candidate will possess a blend of deep technical expertise, strategic leadership capabilities, and a passion for operational excellence.
Educational Background
- A minimum of a Bachelor of Science (B.S.) degree in Engineering (Chemical, Mechanical, or Biomedical), Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline is required.
- An advanced degree (M.S., M.B.A., or Ph.D.) is highly preferred.
Professional Experience
- A minimum of 15+ years of progressive experience within the pharmaceutical or biotechnology industry, with at least 10 years in a leadership role directly overseeing aseptic/sterile drug product manufacturing.
- Demonstrated experience managing large-scale, commercial fill-finish operations for biologics and/or complex parenteral drugs.
- Proven track record of successfully leading teams through multiple regulatory inspections (e.g., FDA Pre-Approval Inspections, general cGMP inspections) with positive outcomes.
- Extensive hands-on experience with sterile manufacturing technologies, including isolators, RABS, automated filling lines, lyophilizers, and automated visual inspection systems.
- Experience with technology transfer, process validation, and the launch of new commercial products is essential.
Skills & Competencies
- In-depth, expert-level knowledge of global cGMP standards and regulatory requirements for sterile drug products.
- Exceptional leadership and people management skills with the ability to inspire, motivate, and develop a large and diverse team.
- Strong strategic thinking and business acumen, with the ability to translate corporate goals into actionable departmental plans.
- Excellent problem-solving and decision-making skills, with a data-driven and methodical approach.
- Superior communication and interpersonal skills, capable of effectively presenting complex information to executive leadership, regulatory agencies, and cross-functional teams.
- Demonstrated financial management skills, including budget development, forecasting, and capital project justification.
- A strong commitment to creating a culture of safety, quality, and continuous improvement.
Benefits & Perks Offered
Our client offers a highly competitive and comprehensive compensation and benefits package designed to attract and retain top-tier executive talent. This includes:
- Competitive Base Salary
- Aggressive Annual Performance-Based Bonus Program
- Long-Term Incentive Plan (e.g., Stock Options, Restricted Stock Units)
- Comprehensive Health, Dental, and Vision Insurance Plans
- Generous 401(k) Retirement Plan with Company Match
- Substantial Paid Time Off (PTO), including vacation, sick leave, and holidays
- Full Relocation Assistance Package for qualified candidates
- Professional Development and Continuing Education Support
- Employee Wellness Programs
- Life and Disability Insurance
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a transformative manufacturing leader with the experience and drive to excel in this critical role, we encourage you to apply. To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your qualifications and leadership philosophy. All applications will be treated with the strictest confidence.
For more information or to discuss your suitability for this or other executive roles in the life sciences sector, please connect with our Aseptic Manufacturing, Injectable Production & Sterile Operations recruitment team. We look forward to reviewing your application and exploring this exciting opportunity with you.
