Associate Director, Pilot Plant Operations

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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
 

Gilead Sciences currently has an excellent opportunity for a highly motivated scientist to join our Active Pharmaceutical Ingredient (API) Pilot Plant Operations group in the Pharmaceutical Development & Manufacturing (PDM) organization.  With your commitment and drive, you will be part of a cross-functional drug development team whose goal is to develop curative medicines helping millions of people live healthier, more fulfilling lives.  The API Pilot Plant Operations team manages state-of-the-art manufacturing facilities in which we manufacture small molecule APIs for clinical trials.  Critical to the success of this role will be partnering with the scientists of the Process Chemistry team to execute safe, flexible, and compliant manufacturing.

Essential Duties and Job Functions:

·       Responsible for safe, flexible, and compliant manufacture of drug substances in GMP facilities.

·       Address environmental, quality, and safety concerns.

·       Coordinates production schedules based on project priorities.

·       Ensures appropriate change management and qualification of new and upgraded equipment.

·       Ensures manufacturing areas, equipment, and procedures meet all current regulatory requirements.

·       Contributes to authoring of and reviewing pre- and post-execution batch production records.

·       Identify and implement cost reductions in materials, equipment, or overhead.

·       Supervision of manufacturing staff.

·       Advise members of project teams in the design and execution of API manufacturing, considering economic, sustainability, regulatory and safety factors.

·       Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

·       Demonstrate excellent verbal communication skills and interpersonal skills.

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