Senior Vice President of Clinical Production

2 weeks ago

Foster City, California, United States Gilead Sciences Full time
Position Overview
The Senior Vice President of Clinical Manufacturing is a crucial collaborator in the advancement of clinical production initiatives.

This executive role entails providing strategic insight and leadership for our partners, ensuring operational excellence at the clinical manufacturing site.

This position offers a unique chance for a leader to engage in the establishment of a pioneering project that will develop into our inaugural biologics manufacturing facility.

Success in this role hinges on the leader's ability to cultivate relationships and enhance the manufacturing division's reputation as a sought-after collaborator, exemplifying Gilead's leadership principles.

The role encompasses oversight of a multifaceted manufacturing site, including small molecule clinical drug substance, oral drug product, and biological drug substance production.

Key Responsibilities:
- Collaborate in the development and expansion of the manufacturing location.

- Formulate medium- and long-term strategic goals for clinical manufacturing and guide the management team in operational plan development and execution.

- Communicate effectively to gain support for business objectives and future vision, ensuring alignment with strategic goals.

- Partner with various functions to advocate for and implement technological advancements.
- Uphold the highest safety standards and operational integrity.

- Provide leadership to direct reports, fostering a skilled team through recruitment, training, and professional development to meet both immediate and future business demands.

- Anticipate changes in industry trends and regulatory landscapes that may influence Gilead's operational needs, positioning the function to adapt proactively.

- Determine staffing projections in collaboration with senior management. Mentor and develop team members, conducting regular meetings to establish goals and objectives.

- Collaborate on capital projects with Technical Development, Quality Assurance, and Corporate Engineering to ensure timely and budget-compliant delivery of new manufacturing capabilities.

- Lead the creation of site manufacturing budgets in partnership with departmental leaders, guided by the head of global manufacturing.

Manage expenditures in line with the approved budget, maintaining thorough budgetary oversight and addressing any deviations.
- Work closely with Technical Development to facilitate the efficient transition from bench to plant for compliant clinical manufacturing.

- Coordinate internal technology transfers from pilot to commercial scale production for small molecule drug substances, biological drug substances, and oral drug products.

Qualifications:

- Extensive experience and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and a solid understanding of global regulatory requirements.

- Exceptional verbal, written, and interpersonal communication skills are essential, along with strong influencing capabilities.
- Proven success in developing strategies that yield results.
- Expertise in managing manufacturing quality within a large, global pharmaceutical organization.
- Strong people and project management skills.
- In-depth knowledge of industry best practices and relevant regulatory guidance, including pharmaceutical GMPs and ICH standards.
- Proficient in quality risk assessment and management methodologies, with a successful track record in risk mitigation.
- Experience collaborating effectively with senior scientific and operational personnel.
- Ability to devise solutions for complex challenges requiring creativity and innovation.
Education:
- 20+ years of experience with a degree in Chemistry, Biochemistry, Chemical Engineering, or related fields.

- An advanced degree such as an MS, MD, PharmD, PhD, or an MBA is preferred.

- Experience leading biologics or small molecule manufacturing teams.
- Familiarity with regulatory submissions, including IND and BLA/NDA, as well as post-marketing processes.
- Comprehensive understanding of ICH guidelines and GMP requirements.
- Strong grasp of current industry trends and regulatory expectations in pharmaceutical manufacturing, including emerging technologies and methodologies.
- Outstanding leadership, interaction, and communication skills are essential.

Leadership qualities sought include the ability to develop high-performing teams, foster cross-functional collaboration, and maintain a strategic vision.

Gilead Core Values:
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)

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