Associate Vice President / Vice President, Manufacturing Operations & Site Head

Contenido de trabajo

The AVP / VP of Manufacturing Operation will lead TaiMed’s monoclonal antibody cGMP manufacturing organization to produce clinical and commercial products across the manufacturing network.

The position also oversees the newly formed CDMO business. This role is responsible for developing manufacturing strategies and executing operations to ensure financial, timeline, and quality objectives are attained. The leadership role manages all aspects of manufacturing operations, including material management, manufacturing, quality assurance, quality controls, facility engineering, and production planning.

This position will report to the CEO. Due to the nature of manufacturing, the qualified candidate prefers to be a subject matter expert in cGMP manufacturing.

Primary responsibilities of the role:

• Manges cGMP manufacturing conducted at internal and external cGMP manufacturing sites
• Provides leadership for the cGMP manufacturing functions, including process development, manufacturing, material management, quality assurance, quality controls, facility engineering, and CDMO business.
• Manages CMO business and is responsible for negotiating service/supply agreements, SOWs, and master service agreements
• Manages budget and resources related to the cGMP manufacturing network
• Ensures manufacturing compliance with regulatory and cGMP standards

Qualification:

· Master or Ph.D. in biologics, engineering, pharmaceutics, or related science fields. Ph.D. is strongly desired

· Minimum of 10 years of experience in leading cGMP manufacturing operations of biologics and/or pharmaceuticals

· Experienced in leading a cGMP manufacturing site and familiar with people, operation, priority, and budget management, is highly desired

· Working experience in regulatory filings (IND, BLA, MAA) and cGMP inspections by regulatory authorities

· Demonstrated leadership capability and track record of developing and leading high-performance teams and organizations

· Ability to work successfully in a small organization

· Extensive technical experience in process technical transfer, scale-up, qualification, validation, and commercial operations

· Demonstrated problem-solving skills and strong organizational skills

· Experienced in managing CDMO business with respect to negotiating contracts and preparing SOWs and master service agreements

· Outstanding written and verbal communication/listening and presentation skills