Gilead Sciences
Exec Director, Formulation & Process Development
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Executive Director, Formulation and Process Development – lead the development and commercialization of small molecule drug products, including proteins/peptides, from drug discovery to product commercialization. Provide leadership and strategic guidance as a member of the Technical Development Leadership Team, shaping development and commercialization strategies across modalities. Responsibilities
Provide leadership and direction to the Formulation and Process Development organization (department of >70 scientists) for small molecule formulations including oral solid dosage forms and sterile injectables. Design and develop products for all small molecules, peptides, and synthetic oligonucleotides from lead optimization to commercialization; provide technical, operational, and strategic guidance across development stages (lead optimization of pre-clinical candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical candidates, and commercial support). Demonstrate thorough understanding of cGMP environments and compliance requirements both internally and with external manufacturing operations. Provide guidance and strategic direction through interactions with FP&D teams. Ensure successful transfer of new products and technology to internal and external manufacturing sites, including generation of knowledge to support product robustness targets. Serve as a senior member of the Technical Development Leadership Team, responsible for developing and establishing small molecule strategy. Evaluate and implement new technologies to drive innovation in Formulation and Process Development for small molecules. Drive development and implementation of new systems to improve project execution and data management. Lead collaborations with Gilead PDM functions (Quality Assurance, CMC Regulatory, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain). Maintain strong relationships with key stakeholder functions including Research, Clinical Development, Clinical Supply Management and Product Strategy Teams by providing technical and strategic input. Hire, mentor and develop team members within the organization. Support regulatory filings by guiding the draft, review, and approval of CMC sections; support agency interactions and inspections. Provide technical support to internal and external cGMP manufacturing operations. Develop and manage the department budget. Qualifications
Ph.D. in pharmaceutical sciences or related field with at least 15 years of experience in pharmaceutical development and progressively responsible roles. Deep knowledge of drug product development, technology transfer to manufacturing, and regulatory frameworks (FDA and international CMC). Proven ability to operate effectively in a multidisciplinary, highly matrixed environment. Demonstrated ability to build and lead a high-performing team. Excellent decision-making, written and verbal communication skills; strong leadership and interpersonal abilities. Leadership qualities include collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, and executive presence. People Leader Accountabilities
Create Inclusion – model and embed diversity in management and team practices. Develop Talent – coach and guide employees on performance and potential, providing timely feedback for growth. Empower Teams – align goals with organizational objectives, remove barriers, and connect teams to the broader ecosystem. Gilead Core Values
Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences supports a diverse workforce and provides accommodations as required by law during the job application process.
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Executive Director, Formulation and Process Development – lead the development and commercialization of small molecule drug products, including proteins/peptides, from drug discovery to product commercialization. Provide leadership and strategic guidance as a member of the Technical Development Leadership Team, shaping development and commercialization strategies across modalities. Responsibilities
Provide leadership and direction to the Formulation and Process Development organization (department of >70 scientists) for small molecule formulations including oral solid dosage forms and sterile injectables. Design and develop products for all small molecules, peptides, and synthetic oligonucleotides from lead optimization to commercialization; provide technical, operational, and strategic guidance across development stages (lead optimization of pre-clinical candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical candidates, and commercial support). Demonstrate thorough understanding of cGMP environments and compliance requirements both internally and with external manufacturing operations. Provide guidance and strategic direction through interactions with FP&D teams. Ensure successful transfer of new products and technology to internal and external manufacturing sites, including generation of knowledge to support product robustness targets. Serve as a senior member of the Technical Development Leadership Team, responsible for developing and establishing small molecule strategy. Evaluate and implement new technologies to drive innovation in Formulation and Process Development for small molecules. Drive development and implementation of new systems to improve project execution and data management. Lead collaborations with Gilead PDM functions (Quality Assurance, CMC Regulatory, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain). Maintain strong relationships with key stakeholder functions including Research, Clinical Development, Clinical Supply Management and Product Strategy Teams by providing technical and strategic input. Hire, mentor and develop team members within the organization. Support regulatory filings by guiding the draft, review, and approval of CMC sections; support agency interactions and inspections. Provide technical support to internal and external cGMP manufacturing operations. Develop and manage the department budget. Qualifications
Ph.D. in pharmaceutical sciences or related field with at least 15 years of experience in pharmaceutical development and progressively responsible roles. Deep knowledge of drug product development, technology transfer to manufacturing, and regulatory frameworks (FDA and international CMC). Proven ability to operate effectively in a multidisciplinary, highly matrixed environment. Demonstrated ability to build and lead a high-performing team. Excellent decision-making, written and verbal communication skills; strong leadership and interpersonal abilities. Leadership qualities include collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, and executive presence. People Leader Accountabilities
Create Inclusion – model and embed diversity in management and team practices. Develop Talent – coach and guide employees on performance and potential, providing timely feedback for growth. Empower Teams – align goals with organizational objectives, remove barriers, and connect teams to the broader ecosystem. Gilead Core Values
Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences supports a diverse workforce and provides accommodations as required by law during the job application process.
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