Principal Scientist, Biologics Pivotal Formulation & Process Development

Gilead Sciences, Inc.•Foster City, CA

34d

About The Position

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. The Principal Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Requirements

PhD / PharmD with 5+ years of relevant experience
MA / MS degree with 8+ years of relevant experience
BA / BS degree and 10+ years of relevant experience
Degree in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields
Industry experience in biologics CMC development

Nice To Haves

End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences.
Experience of IND and/or BLA fillings.
Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.
Working knowledge of lab automation, data science, and knowledge management.
Hands-on in lab execution and has experience of training junior members.
Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
People management experience is strongly desired.
Experience working with contract development and manufacturing organization is highly preferred.

Responsibilities

Lead key elements of complex programs, such as portfolio projects, department initiatives, scientific collaborations, new technology assessments, and workflow optimization to help the department reach its goals.
Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations.
Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions
Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentations.
Work with functional leaders to develop a functional handbook to pursue business process and technical excellence.
Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
May coach direct reports.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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