Senior Vice President - Chemical Development and Manufacturing Operations (CDMO)

Job Description:

The Senior Vice President leads the Chemical Development and Manufacturing Operations (CDMO) organization at Gilead. The CDMO organization is responsible for the chemical process development, manufacture and supply of all Gilead’s small molecule drug substances from the research stage, through clinical development, marketing approval, commercial production and drug substance supply globally. This role is based at Gilead’s corporate headquarters in Foster City, California. CDMO has employees at four locations in four countries, including a process development and commercial production site in Canada, and process research and development and clinical production facilities in California.

In this role you will be accountable for:

• Process chemistry for rapid and innovative development and scale up of target compounds in Gilead’s R&D pipeline

• GMP manufacturing of drug substances for development programs and commercial products

• Technology transfer, chemical outsourcing, and internal and external manufacturing to deliver a robust supply chain for all drug substances incorporating quality, safety, compliance, cost effectiveness, sustainability and reliability to meet global demands

• Drug substance regulatory strategy to ensure product quality, facilitate regulatory approvals globally and achieve operational flexibility of supply chain

• Leading the CDMO organization of 500+ employees, you will provide vision and direction on:

• Fostering an inclusive workplace, creating staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety and achieving high performance

• Operational focus, fiscal accountability and long-term strategy in sync with R&D pipeline, commercial portfolio and company strategy

Knowledge and Skills:

• Sound knowledge of organic chemistry, process engineering and plant operations

• Proven track record of establishing and delivering a robust supply chain for diverse drug substance portfolios to meet global product demand

• Experience with small molecule drug substance manufacturing networks

• Well versed in drug substance manufacturing control strategies

• Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning small molecule drug substance

• Strong business acumen including business contracting expertise

• Experience with CMC requirements for drug development of new molecular entities

• Proven ability to lead high performing teams

• Typically requires a PhD, MS, or BS in chemistry with 20+ years of relevant experience

To apply, visit: https://apptrkr.com/1678060