Senior Manager, Tech Transfer Project Management

Responsibilities

• Lead and manage multiple concurrent clinical and commercial New Product Introduction (NPI) projects for aseptic manufacturing of biologics or small molecules.
• Define product transfer scope, timelines, and resource requirements to meet global technical transfer schedules and clinical demands.
• Develop comprehensive work plans in collaboration with cross-functional teams including Technical Services, QA, QC, Validation, and Engineering.
• Oversee daily project team workflows, ensuring milestones such as machine line trials, installation, commissioning, and PPQs are met.
• Ensure all product transfers comply with regulatory requirements, cGMPs, GLPs, and safety standards.
• Provide regular status updates and strategic reporting to senior management to support key decision-making.
• Represent the site in NPI-focused meetings with corporate stakeholders to bridge communication gaps.

Requirements

• Bachelor's Degree and 8 years of relevant experience, OR Master's Degree and 6 years of experience, OR a Ph.D.
• Proven experience in the pharmaceutical industry.
• Strong project management experience.
• Working knowledge of cGMPs and GLPs.

Preferred Qualifications

• 10+ years of experience in the pharmaceutical industry with a focus on small molecule or biologics fill/finish, inspection, labeling, and packaging.
• 5+ years of experience successfully serving as a project manager.
• Demonstrated leadership ability in managing complex NPI or technology transfer projects.
• Experience interfacing with senior management and cross-functional global teams.
• Proficiency in Microsoft Office applications.

About the Company

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines for serious diseases. For more than 35 years, Gilead has tackled challenges such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to improve lives and ensure global access to life-changing therapies.