Senior Research Scientist II, Purification Process Development – Pivotal & Commercial Biologics

Job Description

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

Senior Research Scientist II, Purification Process Development Pivotal & Commercial Biologics

At a future date this position will relocate to the Gilead corporate HQ in Foster City, CA

The Senior Research Scientist II, Purification Process Development (Pivotal and Commercial) will be responsible for leading all aspects of purification development including process development and process characterization at internal or external facilities for Gilead biologics entities during pivotal and commercial development phases.

He / she will also lead projects for purification process technology development, platform process evolution, and related regulatory documentation.

Key Responsibilities :

• Hands-on technical leadership for the development, characterization, tech transfer and GMP manufacturing support of pivotal and commercial biologic purification processes.
• Manage and mentor research associates and members of project teams in the initiation and execution of laboratory experimentation, considering appropriate safety, economic and regulatory factors.
• Evaluate external service providers and oversee development activities.
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author, review, and approve development reports, process descriptions, batch records, regulatory filings, and process validation and characterization reports.

The candidate must demonstrate excellent verbal and technical writing skills.

• Represent the Pivotal and Commercial Purification Development Department on product development / CMC teams.
• Lead and / or participate on cross-functional initiatives.
• Support investigations and identify root causes for critical deviations.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• Contribute to business process improvements related to pivotal / commercial process development.

Qualifications / Skills / Experience :

• Ph.D. with 5+ years OR M.S. with 10+ years OR 12+ Years with BS experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation / removal is required.
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Antibody drug conjugate experience is a plus.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is desired.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
• Working knowledge of lab automation, data management, data science, knowledge management and data protection.
• Passion for inclusion : knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he / she works.

The salary range for this position is : $173,910.00 - $225,060.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. 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*.