Job Description
Job Description
General Responsibilities:
This individual leads the internal and external manufacturing, supply chain, and facilities and engineering functions that support the cGMP production of preclinical, clinical, and late-stage commercial products. The VP of Manufacturing develops and executes the clinical manufacturing plan aligned with clinical supply forecasts ensuring effective capacity utilization and resource management and consistent performance to plan. This leader collaborates with process and analytical development to transfer and qualify new processes into manufacturing. The VP of Manufacturing is critical for the organization’s growth and the preparation of operations for commercial readiness, as the company moves towards a BLA filing.
Strategic Responsibilities:
- Execute the manufacturing vision and strategy for the Company, including implementation of production processes, platform systems, and quality systems as governed by corporate strategy
- Partner closely with Clinical and Quality Assurance teams to align on quality requirements, production timelines, and regulatory compliance to support clinical trial success and ensure readiness for commercial scale-up, while maintaining high product quality and consistency across all product phases
- Execute the manufacturing launch plan for our lead cell-based, gene therapy candidate to ensure supply demands are met from clinical studies through commercial launch and beyond, ensuring effective capacity and resource management and consistent adherence to plan
- Manage, and achieve department Operational Expenditures and Capital Expenditures budgets, standard operating procedures, quality attributes, productivity yields, and other technical and business metrics
- Implement robust contingency plans to mitigate risks related to manufacturing, supply chain disruptions, and regulatory challenges. Ensures the team is prepared to address emergencies or unexpected issues quickly and effectively
- Oversee in-house and external manufacturing and related required activities for clinical material production, including plasmids and vectors
- Participate in employment decisions as required for Manufacturing and other departments
Team Management Responsibilities:
- Build, inspire, and guide a high-performing and quality-minded Manufacturing, Supply Chain, and Facilities/Engineering team by promoting communication, collaboration, and a spirit of unity within the Company
- Mentor and coach senior leaders within the teams to ensure a high level of engagement and a pipeline of future leaders
- Oversee internal workstreams and ensure communication throughout the organization is efficiently managed to provide all employees and managers with current, pertinent, job-related information
- Create a regulatory-compliant work environment by ensuring Right-the-First-Time and Quality First behaviors are exhibited in all activities
- Create an open and transparent work environment for all employees
- Stay up to date on overall team activities, identifying roadblocks, taking appropriate corrective action measures, and collaborating with other departments
- Interact with executive management through communication of challenges and risks to influence decision making and strategy
Internal & External Management Responsibilities:
- Manage technology transfer of existing and new technologies
- Manage and oversee process qualification activities both in-house and at external partners
- Foster collaboration with external suppliers, such as laboratories, contract manufacturers, consultants, and other contract organizations
- Oversee the end-to-end supply chain (plasmid, vector, final product). Ensure efficient management of inventory, sourcing, and distribution networks to meet the needs of clinical trials and commercial launch.
- Develop a training program for manufacturing staff to ensure team members have a clear understanding of manufacturing and compliance procedures and the science behind the procedures
- Develop and maintain operating procedures and policies in accordance with Current Good Manufacturing Practices (cGMPs)
- Partner with Regulatory and assist in the preparation of global regulatory filings and serve as a subject matter expert during regulatory interactions
Competencies:
Ethics and Dependability: Follows instructions to achieve Company goals, takes responsibility for own actions, treats people with respect, appropriately maintains confidential information, has a high regard for personal integrity and the integrity of team members.
Results: Plans, organizes, and prioritizes deliverables by conveying a sense of urgency, overcoming barriers, maintaining a high level of productivity, and monitoring progress while staying within time and budget requirements. Ability to successfully execute multiple tasks simultaneously across multiple departments in a fast-paced environment. Possesses ability to produce sound and well-reasoned work verbally and in writing.
Accountability: Identifies what needs to be done and doing it before being asked or before the situation requires it. Takes personal ownership in the Company’s success, accepts full responsibility for oneself and the team, and delivers on commitments.
Collaboration: Supports and helps employees in their work to contribute to the overall success of the Company. Develop, maintain, and strengthen internal and external partnerships, including cross-functional departmental relationships. Maintains networking within the scientific and regulatory community.
Adaptability: Develops alternate solutions to challenges, utilizes resources to aid in problem solving, ability to deal with frequent changes and delays while maintaining a positive solutions-oriented attitude.
Leadership: Develops effective working relationships with management, peers, and direct reports. Gains the confidence and trust of others by fulfilling commitments, accepting responsibility, and expressing views openly and constructively. Ensures appropriate cross-functional collaboration.
Computer Skills:
- To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software.
Education:
- Degree in biology, chemistry, biomedical engineering, chemical engineering, and/or related life-science or engineering field
- Ph.D or advanced degree preferred
Experience:
- At least 10 years of experience in implementing cell culture systems for cGMP manufacturing
- A minimum of 8 years industry experience, including Director or higher role in the same or similar function at a similar or larger company
- A track record of successes in manufacturing and supply chain, including in-house capabilities and external networks
- Experience with commercial cell culture systems, including single use bioreactors, commercial media formulations, and high cell density cell handling systems.
- Experience in tech transfer and scale up/out of cell culture systems from pilot to production scale, including transfer to various Contract Development and Manufacturing Organizations (CDMOs)
- Strong cross functional leadership skills including refined verbal and written communication skills. Strong engineering skills, including facility fit and process engineering assessment into different facilities.
- Experience with complex regulatory filings, including initial BLA and post-approval regulatory activities
- Experience with inspections by the FDA or other regulatory agencies
- Late clinical stage or commercial cell and gene therapy manufacturing supply experience considered a huge plus