Head of Development

Exec Director, Formulation & Process Development Exec Director, Formulation & Process Development United States - California - Foster City Process/Product Development & Operations Regular
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.
Executive Director, Formulation and Process Development
The Executive Director of Formulation and Process Development will be responsible for leading the development and commercialization of small molecule drug product including proteins/peptides from drug discovery to product commercialization. In addition, the incumbent will be a member of the Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies of all modalities.
Provide leadership and direction to the Formulation and Process Development organization, a department of
Responsible for the design & development of products for all small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization Provide technical, operational, and strategic guidance on a wide range of activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical drug candidates, and commercial support)
Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements.
Provide guidance and strategic directions through interactions with each formulation and process development (FPD) team
Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding 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 such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain,
Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input
Support regulatory filings by guiding the draft, review, and approval of CMC sections; Provide technical support to internal and external cGMP manufacturing operations
D. in pharmaceutical sciences or related sciences with at least 15 years of experience in pharmaceutical development and a record of roles with increasing responsibility
In-depth knowledge and understanding of drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence.
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. Inclusion (Encouraging Diversity)
• Accountability (Taking Personal Responsibility)
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.
Executive Director, Formulation and Process Development
The Executive Director of Formulation and Process Development will be responsible for leading the development and commercialization of small molecule drug product including proteins/peptides from drug discovery to product commercialization. In addition, the incumbent will be a member of the Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies of all modalities.
Provide leadership and direction to the Formulation and Process Development organization, a department of
Responsible for the design & development of products for all small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization Provide technical, operational, and strategic guidance on a wide range of activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical drug candidates, and commercial support)
Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements.
Provide guidance and strategic directions through interactions with each formulation and process development (FPD) team
Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding 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 such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain,
Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input
Support regulatory filings by guiding the draft, review, and approval of CMC sections; Provide technical support to internal and external cGMP manufacturing operations
D. in pharmaceutical sciences or related sciences with at least 15 years of experience in pharmaceutical development and a record of roles with increasing responsibility
In-depth knowledge and understanding of drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence.
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. Inclusion (Encouraging Diversity)
• Accountability (Taking Personal Responsibility)
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
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Full Time/Part Time Full-Time
Remote Type Onsite Required
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