VP, Manufacturing

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

Team Management Responsibilities :

Internal & External Management Responsibilities :

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 :

Education :

Experience :