26 applicants

Company

Original Job Post

Gilead Sciences · 3 days ago

Senior Director, Purification Process Development

Foster City, CA

Full-time

Onsite

Director

$238K/yr - $308K/yr

10+ years exp

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BiopharmaBiotechnology

H1B Sponsorship

Actively Hiring

Comp. & Benefits

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Responsibilities

Hire, mentor, and develop team members to build a world-class Biologics Purification Process Development organization.

Establish and maintain state-of-the-art purification labs for efficient development and process characterization.

Provide leadership and oversight for multiple pivotal and commercial biologic programs.

Develop and characterize robust purification processes to support clinical and commercial manufacturing.

Lead purification process development and transfer to manufacturing facilities.

Support regulatory filings and inspections related to CMC sections.

Build strong relationships with key stakeholder functions.

Ensure compliance with cGMP practices and requirements.

Drive development and implementation of new process technologies.

Stay updated on trends and advancements in the Biopharmaceutical industry.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Process characterizationCommercial supportProcess transferTechnical leadershipFDA guidelinesEMA guidelinesICH guidelinesQuality complianceCMC sectionsLab automationData scienceKnowledge managementSingle-use manufacturing technologyCGMP guidelinesBusiness acumenResource managementBudget managementProgram milestonesStaff goal settingProblem-solvingLeadershipCollaborationAccountabilityCross-functional engagementInfluence

Required

Ph.D. in Chemical Engineering, Biochemistry, or related fields with 10+ years’ experience OR M.S. with 12+ years’ experience OR B.S. with 14+ years industrial experience in biologics purification development with people leader accountabilities.

Extensive experience in pivotal development, process characterization and commercial support of harvest, chromatography, TFF and viral filtration operations.

Demonstrated experience in process transfer to manufacturing facility and technical leadership in process troubleshooting.

Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in commercial filings (BLA, MAA) and post approval changes.

Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.

Strong business acumen, be able to balance resource, budget and program milestones.

Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.

Benefits

Company-sponsored medical

Dental

Vision

Life insurance plans

Company

Gilead Sciences

Glassdoor

3.9

Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

Founded in 1987

Foster City, California, USA

10,001+ employees

http://www.gilead.com

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (163)

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2020 (226)