Senior Research Scientist I, Purification Process Development - Pivotal & Commercial Biologics at Gilead Sciences

Location: USA

About Gilead Sciences

At Gilead, we are on a mission to create a healthier world for everyone. For over 35 years, we have been revolutionizing treatments for diseases such as HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies aims to improve lives and ensure global access to these life-saving treatments. Join us in our fight against the world’s biggest health challenges through collaboration, determination, and an unwavering commitment to making a difference.

Why You Should Work at Gilead

Everyone at Gilead plays a crucial role in the discovery and development of groundbreaking scientific innovations. Our employees are our greatest asset. We are seeking passionate and ambitious individuals ready to make a direct impact and help us achieve our bold ambitions. As a people leader, you are key to evolving our culture and fostering an inclusive, developmental, and empowering environment.

Job Description

The Senior Research Scientist I, Purification Process Development (Pivotal and Commercial) will lead all aspects of purification development, including process characterization at internal or external facilities for Gilead biologics entities. The candidate will also lead projects on purification process technology development and regulatory documentation during pivotal and commercial development phases.

Key Responsibilities

• Provide hands-on technical leadership for biologic purification processes development, characterization, tech transfer, and GMP manufacturing support.
• Manage and mentor research associates and project teams, ensuring safety, economic, and regulatory factors are met.
• Evaluate and oversee external service provider activities.
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author and review development reports, process descriptions, batch records, regulatory filings, and validation reports.
• Represent the Pivotal and Commercial Purification Development Department on product development/CMC teams.
• Lead or participate in cross-functional initiatives.
• Identify root causes for critical deviations in investigations.
• Travel to support technology transfers and provide oversight at external manufacturing facilities.
• Contribute to business process improvements related to pivotal/commercial process development.

Qualifications and Experience

• Ph.D. with 2+ years, M.S. with 8+ years, or B.S. with 10+ years of experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Hands-on experience in purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.
• Experience in pivotal stage purification process development and GMP facilities implementation. Antibody drug conjugate experience is a plus.
• Excellent communication, technical writing, and presentation skills.
• Experience writing CMC sections of regulatory filings (BLA, MAA) and post-approval change filings desired.
• Proven 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, and knowledge management.
• Commitment to diversity and inclusion, modeling inclusive behavior, and embedding the value of diversity in the workplace.

Compensation

The salary range for this position is $177,905.00 - $230,230.00. Compensation is based on factors such as experience, qualifications, and geographic location. This role may also be eligible for an annual bonus, stock-based incentives, paid time off, and a comprehensive benefits package including medical, dental, vision, and life insurance plans.

For more information on our benefits, visit: .

Equal Employment Opportunity

Gilead Sciences, Inc. is an Equal Opportunity Employer. We are committed to a diverse and inclusive workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, disability,