Exec Director, Formulation & Process Development

At Gilead, we’re creating a healthier world for all people. 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. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

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.

Responsibilities:

• Provide leadership and direction to the Formulation and Process Development organization, a department of >70 scientists for small molecule formulations including oral solid dosage forms and sterile injectables
• 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
• Hire, mentor and develop team members within the organization
• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
• Provide technical support to internal and external cGMP manufacturing operations
• Develop and manage department budget

Qualifications:

• Ph.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
• Previous success working effectively in a multidisciplinary, highly matrixed environment
• Demonstrated ability to build a team and develop a high performing organization
• Excellent decision-making, written and verbal communication skills
• Proven ability to lead high performing teams
• Exceptional interaction, leadership and command skills are required
• Leaders