Technical Associate Director, Process Technologies and Development

Technical Associate Director, Process Technologies and Development United States - California - Foster City Process/Product Development & Operations Regular

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

Job Responsibilities

Technical leadership of engineering projects related to aseptic drug product processing, facilities, and equipment

Pathfinding in the design, optimization, and problem solving of complex systems, particularly where conventional/established approaches are not appropriate or have not succeeded

Developing feasible timelines which reflect physics, technical and financial constraints, deliver high quality, robust solutions, address desired business outcomes, and impact business success

Apply fundamental engineering principles to the design, development, scale-up, and validation of robust processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals

Serve as a subject matter expert for clinical and commercial drug product processing operations

Share expertise and provide guidance/mentorship to nurture and develop the skills of talented junior team members

Reinforce a culture of continuous learning, technical rigor, data driven decision making, and patient-oriented ethics as keys to technical and business success

Spearhead the establishment and equipping of a state-of-the-art sterile drug product process engineering lab, including the procurement and creation of experimental apparatus, instrumentation, and tools necessary to fulfill the lab’s deliverables

Evaluate new/novel and established technologies and/or equipment most appropriate for implementation in aseptic manufacturing of parenteral drug products

Provide technical leadership for the build out of new clinical and/or commercial drug product manufacturing facilities and manufacturing lines

Provide technical leadership for facility fit analysis and site selection for drug product clinical and commercial, new processes and technology transfers

Author sections of regulatory documents (e.g., IND, NDA, IMPD, BLA, PAS) in support of global regulatory submissions

Knowledge, Experience and Skills

B.S. degree in packaging engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of 10 years of pharmaceutical packaging experience are required. A combination of advanced degree(s) with comparable levels of relevant industry experience is acceptable

Excellent verbal, written, and interpersonal communication skills are required.

Must be able to write clear, concise, and error-free documents.

Expert knowledge of aseptic drug product manufacturing, relevant cGMP standards, regulations, health authority guidance, and health authority expectations in regions including the United States (FDA) and the…