Vice President, Manufacturing & Supply

Job Purpose

Ocugen’s Vice President, and Head of Manufacturing will be responsible for overseeing manufacturing, process development, process engineering, tech-transfer and internal / external (CDMO) sites for Ocugen’s product pipeline- late stage to commercial. He / she will be responsible for end-to-end supply chain for the manufacture and delivery of clinical product to support Ocugen’s global clinical trials and commercial supplies. Along with building the function of manufacturing and supply chain this leadership team member will be responsible for ensuring product is produced with high efficiency and adherent to cGMP and regulatory agency standards. This position will also be responsible for Quality Control and commercial cGMP testing function and reports directly to the Chief Executive Officer.

Duties and Responsibilities

• Represent Ocugen’s Executive Leadership Management team and lead by example, building a strong team in line with growth and retaining top talent.
• You will be responsible for all manufacturing and supply chain functions encompassing multiple therapeutic areas / product lines (e.g., vaccines, cell and gene therapies, biologicals).
• Your group will be supporting and guiding R&D team during early phase of development (Phase I / II clinical supplies) to minimize issues for future tech-transfer, collaborating with R&D to ensure Tech Transfer and scale up processes are timely and efficient.
• Your group will be responsible for all cGMP clinical supplies including process validations in support of regulatory approvals. You will be transitioning all relevant processes from R&D to manufacturing sites with the support of R&D, and efficiently supporting clinical and commercial supply to meet demand.
• Your group will be responsible for establishing and maintaining Quality Control testing operations using internal labs and external CROs as needed.
• Your group will be responsible for identifying and forging partnerships with CDMOs as needed in a timely manner to support our clinical / commercial needs.
• Your group will be responsible for all supply planning to match late-stage clinical / commercial needs by closely working with R&D and commercial teams.
• You will be responsible for building a strategy for futuristic manufacturing organization and infrastructure and execute it effectively (may include capital projects and acquisitions as needed).
• Group will be responsible for managing cGMP facilities construction and operation.
• Continuous improvements and management of efficient COGS are critical. Also, strong internal partnerships including R&D, quality and regulatory are essential.
• You will be responsible for providing updates to Board and outside groups as necessary.

Qualifications

Travel to as required, 35%.