Sr Scientist, Process Development

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

Key Responsibilities

Lead, mentor, coach, and develop technical staff within and outside the group in all aspects of downstream process development, including protein purification, bioconjugation (antibody-drug conjugates), and new technology implementation.

Design and execute experiments to develop efficient, effective downstream purification processes using multiple chromatography modes, filtration technologies, and ultrafiltration / TFF.

Drive new technology development and implementation to enhance downstream platforms and improve process efficiency.

Author and review technical documents, development reports, SOPs, manufacturing batch records, and CMC sections of regulatory submissions (IND, INDa, BLA).

Transfer downstream processes to manufacturing sites, CMOs, and partner sites, ensuring successful scale-up and implementation.

Represent Downstream Process Development on cross-functional teams and contribute to strategic initiatives.

Produce significant internal / external documents or publications supporting company goals.

Basic Qualifications

BS degree with at least 8 years of industry experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

MS degree with at least 6 years of industry experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

Familiarity with protein conjugation process chemistry and formulation.

Hands-on experience in protein purification, thorough understanding of chromatography, and familiarity with AKTA systems.

Extensive knowledge of impurity removal strategies and product variant control; strong chromatography and / or conjugation experience preferred.

Proven track record in scaling up, transferring, and supporting purification processes from bench to pilot / commercial scale in GMP environments.

Experience with statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts.

At least 3+ years of experience supervising technical staff with strong management and leadership skills.

Excellent organizational skills and ability to manage multiple projects in a fast-paced environment.

Strong communication skills (verbal and written) and ability to build relationships across teams and with external partners.

Preferred Qualifications :

PhD with at least 2 years of experience in biopharmaceutical industry with expertise in protein purification (chromatography, depth / membrane filtration, ultrafiltration / TFF) and antibody-drug conjugates.

The salary range for this position is :

Bay Area : $169,320.00 - $219,120.00.Other US Locations : $153,935.00 - $199,210.00.

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