Gilead Sciences · - California - Foster CityPrepare for this interview
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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 Small Molecule Formulation and Process Development (FPD) provides formulation, process, and manufacturing support and technical expertise throughout research and development, from pre-exploratory to commercialization. A Scientist within FPD may support teams conducting compound screening to enable drug candidate selection, drug substance physio/chemical property assessment and form selection, development of clinical formulations and manufacturing processes, small molecule drug product manufacturing tech transfer and scale-up at internal and external sites, oversight of small molecule drug product manufacturing, and establishment a robust DP formulation and optimized manufacturing process to enable commercial production. FPD scientists develop the small molecule formulation and manufacturing process control strategies and authors technical reports, risk assessments, and regulatory filings from IND to NDA. FPD supports DP manufacturing process validation and provides technical expertise throughout post-approval commercial manufacturing and life-cycle management. Job Responsibilities: Administrative: Organizes, files and retrieves project-related records. Maintains the proper functions of laboratories. Technical: Operates laboratory instrumentation and/or processing equipment and can train others to conduct moderate to high complexity experiments. May be a subject matter expert on one or more pieces of equipment. Designs and executes experiments in support of cross-functional projects. Troubleshoots analytical methods, instrument operation, manufacturing and experimental design. Performs drug substance, drug product intermediate and drug product characterization. May oversee manufacture of GMP clinical and/or development drug products batches. Develops and optimizes manufacturing processes. Works collaboratively with peers from other departments and external partners. Trains less experienced colleagues on techniques required for their duties, while ensuring that quality, safety and environmental standards are maintained. Assists in preparation and review of GMP documentation. Summarizes experimental results and presents conclusions in team meetings and departmental presentations. Authors reports and contributes to regulatory submissions (IND, IMPD, NDA, etc.) Safety & Compliance: Follows Environmental, Health and Safety (EHS) Policies and FPD-specific safety protocols. Maintains workplace compliance to achieve no violations or major observations during EHS or regulatory agency inspections. Completes all required safety and GMP training by the required due date. Ensures that standard operating procedures (SOPs) are followed as written, and required information is recorded properly. Accurately documents results in electronic lab notebook. General: Applies Gilead Core Values and Leadership Commitments to job responsibilities. Demonstrates good verbal communication and interpersonal skills. Works with a collaborative communication and problem-solving spirit. Acts as a resource for other colleagues within the department.
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