Director, Manufacturability Assessment, PDM Biologics

Director, Manufacturability Assessment, PDM Biologics

United States - California - Foster City Process / Product Development & Operations Regular

Job Description

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

The Director, Manufacturability Assessment (Pre-Pivotal) will be responsible for interfacing with the Research organization, collaborating with Protein Therapeutics in molecule assessment and leading PDM manufacturability assessment including end to end PDM functions. She / He is accountable to provide input and to support candidate selection for Gilead’s biologics entities during pre-pivotal phases of development.

Responsibilities :

• Responsible to work with Research and PDM functions to provide PDM support and input to Research molecule assessment.
• Accountable to work with Research for candidate nomination and coordinate PDM resource, activities and timeline.
• Work with Research and Pre-Pivotal leadership team to align and prioritize biologics assets and their development plans.
• Lead PDM cross functional team to assess manufacturability of Gilead’s biologics assets.
• Communicate PDM manufacturability assessment results and recommendations to Research and influence candidate selection.
• Participate in due diligence efforts to assess external biologics assets.
• Responsible to work with project PDM lead and transition development project once it reaches PDM team formation.
• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and PDM functions by providing technical and strategic input.

Qualifications :

Gilead Core Values

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