Executive Director, Purification Process Development - Pivotal & Commercial Biologics

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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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Executive Director, Purification Process Development leads late-stage purification and conjugation process development and characterization for biologics from pivotal through commercial launch, including post-launch lifecycle management. This role sets strategy and provides technical leadership across cross-functional partners (Technical Development, Quality, Regulatory, Manufacturing, and Supply Chain) to deliver robust processes, effective control strategies, and successful clinical/commercial tech transfers and filings. The Executive Director of Purification Process Development (PPD) will be responsible for leading the development and characterization of purification and conjugation processes for biologics programs from the Pivotal and Commercial stages. This responsibility will also include any post launch Life Cycle Management (LCM) development activities. They will also be a member of the Pivotal & Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Development, Global MSAT, and Materials Sciences). Key responsibilities include, but are not limited to: Provide leadership and direction to the Biologics Purification Process organization, a department of scientists and engineers. Accountable for development, characterization, and clinical tech transfer of robust purification processes to support Pivotal clinical and Commercial manufacturing, including Life Cycle Management. This includes accountability for developing an integrated control strategy in partnership with organizations across Technical Development, Quality, CMC Regulatory Affairs, and Manufacturing. Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections. Partner with cross-functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product. Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Gilead Asset Teams by providing technical and strategic input. Demonstrate a knowledge of the cGMP practices and compliance requirements. Serve as a member of the Biologics Pivotal/Commercial Technical Development Leadership Team responsible for developing and establishing late-stage Biologics strategy. Drive development and implementation of new process technologies to meet business and portfolio needs. Remain current on trends and new technology advancements across the Biopharmaceutical industry. Assist with due diligence efforts for possible asset purchases and partnership opportunities. Establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement. Hire, mentor and develop team members within the organization to h