Executive Director, Sterile Process Engineering and Packaging

$274,635 - $355,410/Yr

Gilead Sciences - Foster City, CA

Full-time - Executive

Foster City, CA

Chemical Manufacturing

About the position

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, dedicated to delivering life-saving therapies to patients in need. The Executive Director, Sterile Process Engineering and Packaging (SPEP), will play a strategic leadership role within the Drug Development and Commercial Product Engineering (DDCPE) organization. This role is pivotal in developing clinical and commercial devices, packaging, and fill/finish processes for combination products in Gilead's portfolio. The incumbent will be responsible for establishing global, end-to-end capabilities for the design, development, scale-up, and validation of processes for late-stage sterile drug product unit operations, including assembly and packaging for both small and large molecule parenteral drugs. The Executive Director will foster an environment of cross-functional collaboration, accountability, influence, and technical rigor, working closely with teams such as Formulation, Clinical Packaging, Device Engineering, Manufacturing Operations, and Supply Chain. This role requires a creative, open-minded, and highly motivated individual who is results-oriented and possesses high learning agility. The successful candidate will be an experienced people leader who develops, inspires, and empowers strong teams to achieve Gilead's mission of addressing unmet medical needs and improving life for patients with life-threatening diseases. Specific responsibilities include serving as a member of the DDCPE Leadership Team, providing technical and strategic leadership to sterile drug processes, leading a team to design and validate processes for sterile drug product unit operations, collaborating with various departments to ensure smooth transitions from development to commercialization, and driving the establishment of a state-of-the-art sterile process engineering lab. The Executive Director will also influence regulatory strategies, lead business process initiatives, champion sustainability initiatives, and develop staff capabilities in alignment with Gilead's growth strategies.

Responsibilities

• Serve as a member of the DDCPE Leadership Team responsible for developing and establishing strategy and site operations.
• Provide technical and strategic leadership to sterile drug processes for late-stage programs to enable the manufacture of high-quality, cost-effective, compliant, and lifesaving parenterals to patients.
• Lead current team (~4 FTE's) and build out group to design, develop, scale-up, and validate processes for sterile drug product unit operations.
• Closely collaborate with Clinical Packaging, Device Engineering, and Manufacturing Operations to ensure smooth transitions and appropriately staged investments from early development to commercialization.
• Drive the establishment and maintenance of a state-of-the-art sterile process engineering lab.
• Keep abreast of technology, market and regulatory trends in sterile processing, assembly, and packaging of combination products and identify portfolio gaps and opportunities for strategic innovation.
• Influence regulatory strategies; drive and provide oversight and reviews of the relevant sections related to sterile process unit operations and packaging for regulatory filings.
• Drive and where appropriate lead the selection and qualification and maintenance of a platform parenteral container closure system for both vials and pre-filled syringes.
• Lead business process, operations, and technology initiatives to improve project execution and efficiency; drive a culture of innovation, high-quality, and science-based engineering.
• Champion sustainability initiatives within to meet Gilead's ambition to reduce greenhouse gas emissions by 2030.
• Remove roadblocks related to complex technical or business challenges faced by the SPEP team.
• Lead, develop, and coach staff, creating strategies to evolve the capabilities of the organization in alignment with Gilead's growth strategies.
• Lead by example in demonstrating Gilead's Core Values of Integrity, Inclusion, Teamwork, Excellence, and Accountability.

Requirements

• Advanced degree in science, pharmaceutics, engineering, or related field, with relevant industry experience: BA/BS degree and a minimum of sixteen (16) years of experience, OR a Ph.D. degree and a minimum of fourteen (14) years of relevant industry experience.
• At least ten (10) years of significant leadership/management experience.
• Thorough knowledge of FDA and cGMP standards, parenteral packaging and devices, combination products, and drug product manufacturing and sterile processing.
• Strong technical and scientific acumen with proven ability to develop and implement strategies to optimize and de-risk processes.
• Demonstrated ability to develop and execute organizational and business strategy to bring maximum value to the organization.
• Excellent verbal, written, and interpersonal communication skills are required.
• Demonstrated ability to lead through influence in a matrixed corporate environment and at a senior level within the organization.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.