Director, Global External Manufacturing, OSD
Gilead Sciences
3 months ago
Remote friendly (San Francisco Bay Area)
United States
$210,375 - $272,250 USD yearly
Operations
Director, Global External Manufacturing Oral-Solid Dosage (OSD) leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within a global external contract manufacturing network, ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
Essential Functions / Key Responsibilities
- Execute the external manufacturing network strategy; manage tactical manufacturing strategy, business execution with external manufacturing organizations, and supplier performance.
- Develop department strategy aligned with corporate and PDM goals into functional/departmental objectives.
- Lead cross-functional collaboration with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals.
- Define technical requirements (with Technical Development); partner with Global Supply Chain on CMO selection; influence network CMO performance to achieve strategic/tactical business outcomes and KPIs.
- Partner with Technical Development and internal Gilead manufacturing sites to execute successful technology transfer and validation of new/existing processes/products to identified CMO(s).
- Manage CMOs to ensure products are manufactured according to the registered process and approved Master Production Record.
- Resolve complex manufacturing and/or compliance issues (deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, change control).
- Facilitate continuous improvement to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- May act as a liaison between the company and governmental agencies.
Qualifications
- Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry.
- Expertise in supply risk management and industry/system best practices.
- Working knowledge of manufacturing principles under current cGMP; solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance.
- Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities/limitations is a plus.
- Ability to travel internationally, including overnight, up to 10%.
- Exceptional verbal and written communication skills; can interact effectively with senior management.
- Demonstrated ability to understand and resolve complex situations.
- Proven leadership capability to contribute to the success of PDM and Gilead.
- 12+ years of progressively responsible experience in a pharmaceutical/biotech organization; BA/BS in science or engineering required; advanced degree desirable.
- MBA can substitute for 10 years relevant experience; PhD can substitute for 8 years.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary), paid time off.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Essential Functions / Key Responsibilities
- Execute the external manufacturing network strategy; manage tactical manufacturing strategy, business execution with external manufacturing organizations, and supplier performance.
- Develop department strategy aligned with corporate and PDM goals into functional/departmental objectives.
- Lead cross-functional collaboration with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals.
- Define technical requirements (with Technical Development); partner with Global Supply Chain on CMO selection; influence network CMO performance to achieve strategic/tactical business outcomes and KPIs.
- Partner with Technical Development and internal Gilead manufacturing sites to execute successful technology transfer and validation of new/existing processes/products to identified CMO(s).
- Manage CMOs to ensure products are manufactured according to the registered process and approved Master Production Record.
- Resolve complex manufacturing and/or compliance issues (deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, change control).
- Facilitate continuous improvement to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- May act as a liaison between the company and governmental agencies.
Qualifications
- Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry.
- Expertise in supply risk management and industry/system best practices.
- Working knowledge of manufacturing principles under current cGMP; solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance.
- Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities/limitations is a plus.
- Ability to travel internationally, including overnight, up to 10%.
- Exceptional verbal and written communication skills; can interact effectively with senior management.
- Demonstrated ability to understand and resolve complex situations.
- Proven leadership capability to contribute to the success of PDM and Gilead.
- 12+ years of progressively responsible experience in a pharmaceutical/biotech organization; BA/BS in science or engineering required; advanced degree desirable.
- MBA can substitute for 10 years relevant experience; PhD can substitute for 8 years.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary), paid time off.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.