Exec Director, Analytical Operations
Gilead Sciences
2 months ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Responsibilities
- Lead and manage a team responsible for creating and executing analytical technology roadmaps to support advanced manufacturing initiatives, including continuous manufacturing and real-time release testing (online/inline analytical technologies, Process Analytical Technologies (PAT), automation, miniaturization, AI/ML, and rapid microbiological testing).
- Leverage existing and novel analytical technologies to harmonize end-to-end analytical control strategies across all Gilead therapeutic modalities in partnership with Technical Development, Quality, Regulatory, and Manufacturing.
- Develop approaches and tools that connect product quality and stability with variations in raw materials, process conditions, and product characterization data.
- Collaborate with stakeholders to evaluate how new analytical technologies affect pipeline progress, comparability strategies, and investigations.
- Oversee analytical lab automation, high-throughput analysis, and AI/ML initiatives to enhance productivity; evaluate advanced technologies for implementation in GMP routine quality control testing.
- Establish an external innovation network by partnering with academic institutions and industry vendors; assess feasibility of emerging analytical technologies and guide development for integration across modalities.
- Collaborate with internal teams and external partners to secure global health authority approval for innovative analytical methods; work with CMC Regulatory Affairs on regulatory engagement strategies (e.g., FDA Emerging Technology Team).
- Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings, and industry consortia.
Qualifications
- Ph.D. in Analytical Chemistry, Pharmaceutical Science, Chemical Engineering, or equivalent; 14+ years of experience in CMC development of small molecule and/or biologic products.
- Industry expert/thought leader with a proven track record enabling and implementing new technologies.
- Extensive experience influencing in a matrix organization.
- Expertise in data sciences, PAT, chemometrics, and automation.
- Proficient in AI/ML applications in the pharmaceutical sector.
- Ability to balance adopting new technology while maintaining data utility.
- Proven ability to lead organizational change initiatives.
- Substantial experience preparing regulatory submissions and engaging with regulatory authorities.
- Strong interpersonal, communication, and collaboration skills; ability to influence senior leaders and stakeholders.
- Commitment to building teams across cultures, technical skills, and organizational levels.
Compensation/Benefits (if applicable)
- Salary range: $281,010.00 - $363,660.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application instructions
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees and contractors).
- Lead and manage a team responsible for creating and executing analytical technology roadmaps to support advanced manufacturing initiatives, including continuous manufacturing and real-time release testing (online/inline analytical technologies, Process Analytical Technologies (PAT), automation, miniaturization, AI/ML, and rapid microbiological testing).
- Leverage existing and novel analytical technologies to harmonize end-to-end analytical control strategies across all Gilead therapeutic modalities in partnership with Technical Development, Quality, Regulatory, and Manufacturing.
- Develop approaches and tools that connect product quality and stability with variations in raw materials, process conditions, and product characterization data.
- Collaborate with stakeholders to evaluate how new analytical technologies affect pipeline progress, comparability strategies, and investigations.
- Oversee analytical lab automation, high-throughput analysis, and AI/ML initiatives to enhance productivity; evaluate advanced technologies for implementation in GMP routine quality control testing.
- Establish an external innovation network by partnering with academic institutions and industry vendors; assess feasibility of emerging analytical technologies and guide development for integration across modalities.
- Collaborate with internal teams and external partners to secure global health authority approval for innovative analytical methods; work with CMC Regulatory Affairs on regulatory engagement strategies (e.g., FDA Emerging Technology Team).
- Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings, and industry consortia.
Qualifications
- Ph.D. in Analytical Chemistry, Pharmaceutical Science, Chemical Engineering, or equivalent; 14+ years of experience in CMC development of small molecule and/or biologic products.
- Industry expert/thought leader with a proven track record enabling and implementing new technologies.
- Extensive experience influencing in a matrix organization.
- Expertise in data sciences, PAT, chemometrics, and automation.
- Proficient in AI/ML applications in the pharmaceutical sector.
- Ability to balance adopting new technology while maintaining data utility.
- Proven ability to lead organizational change initiatives.
- Substantial experience preparing regulatory submissions and engaging with regulatory authorities.
- Strong interpersonal, communication, and collaboration skills; ability to influence senior leaders and stakeholders.
- Commitment to building teams across cultures, technical skills, and organizational levels.
Compensation/Benefits (if applicable)
- Salary range: $281,010.00 - $363,660.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application instructions
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees and contractors).