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Expect deep dives on purification unit ops (e.g. chromatography, filtration), comparability after process changes, commercial readiness pitfalls, and how you prioritize portfolio risk under Gilead-scale biologics programs. Prepare concrete examples of late-stage process decisions you owned.
Strong fit if you have led purification PD into pivotal/commercial biologics and can operate as a senior CMC leader at a large biopharma. Data does not support culture or compensation claims.
As Executive Director of Purification Process Development for pivotal and commercial biologics at Gilead, the day centers on leading purification CMC strategy: reviewing process performance and scale-up data, aligning with manufacturing and quality on commercial readiness, prioritizing tech-transfer risks, and coaching process development leads through pivotal commitments and lifecycle changes.
Relevant focus areas for this title (no cert catalog in data): biologics downstream/purification, pivotal-to-commercial process lock, scale-up and tech transfer, CMC governance, and cross-functional leadership with MS&T, QA, and regulatory.
San Mateo, San Mateo County, California; listed as on-site (not remote).
Executive leadership of purification process development spanning pivotal clinical and commercial biologics manufacturing readiness.
No salary figures or certification resources were provided in the data set.
Website: gilead.com
Public cache only — not an employee review.
Executive Director, Purification Process Development - Pivotal & Commercial Biologics | Gilead Sciences | San Mateo, San Mateo County Role Overview The Executive Director, Purification Process Development at Gilead Sciences is a pivotal role within our team focused on advancing the development of biologic therapies. This position involves leading and managing the purification process development for both pivotal clinical trials and commercial biologics. The ideal candidate will have extensive experience in bioprocess development, with a proven track record of successfully delivering complex projects from concept to commercialization. Your Responsibilities Lead the purification process development team, ensuring efficient and effective execution of project plans. Develop and optimize purification processes for clinical and commercial products, working closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs. Ensure compliance with all relevant regulations and guidelines, such as GMP and FDA requirements. Manage budgets and timelines to deliver projects on schedule while maintaining high-quality standards. Collaborate with external partners and vendors to ensure the timely delivery of critical components for purification processes. What You Bring A minimum of 15 years of experience in biopharmaceuticals, with at least 7-10 years in a leadership role. Demonstrated success in leading and managing cross-functional teams to deliver purification process development projects. Expertise in GMP regulations, FDA guidelines, and other relevant regulatory requirements. A track record of developing and optimizing purification processes for clinical and commercial biologics. Strong problem-solving skills and the ability to drive innovation within the team. More About Gilead Sciences Gilead Sciences is a global research-based biopharmaceutical company that has been dedicated to creating innovative medicines for more than 35 years. Our mission is to fight against some of the world's most challenging health issues, including HIV, viral hepatitis, and cancer. We are committed to improving lives through our work in developing therapies and ensuring their accessibility worldwide. Applying for This Role To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there. Please ensure all required documents are included with your submission. To apply, complete your application directly on this page, or you'll…
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