Senior Manager, Tech Transfer Project Management
Gilead Sciences
11 days ago
On-site
La Verne, CA
Operations
Senior Manager, Tech Transfer Project Management (La Verne, CA) – onsite daily (relocation not offered).
Key Responsibilities
- Lead and manage multiple concurrent clinical/commercial NPI projects for aseptic fill/finish (biologics or small molecule), including equipment for clinical (Line 3 flex fill) and commercial fill lines (Line 1 & Line 2), plus labeling and packaging.
- Define product transfer scope, timelines, and demands from PNGC/PPSC endorsement through manufacturing and release.
- Ensure compliance with regulatory requirements, cGMPs, GLPs, safety, and relevant standards; facilitate gap assessments with SMEs.
- Develop comprehensive product transfer work plans with cross-functional teams (Technical Services, Packaging, QA/QC, Validation, Supply Chain, Regulatory/CMC, EHS, Finance, IT, Engineering).
- Oversee daily project team workflow; drive milestone execution (line trials, installation/debug/startup, ATC, PPQs, product runs/studies).
- Track critical tasks (procurement, documentation, studies) and escalate issues; provide filling/packaging process/equipment guidance.
- Represent La Verne cross-functional team in NPI meetings and lead project review meetings.
- Provide senior management reporting; solve moderately complex problems; exercise sound judgment; improve procedures/processes.
Basic Qualifications
- Bachelor’s + 8 years experience OR Master’s + 6 years OR Ph.D.
Preferred Qualifications
- 10+ years (BS/BA) or 6+ years (MS/MA/MBA) in pharma small molecule/biologics fill/finish/inspection/labeling/packaging.
- 5+ years as a project manager; experience leading complex NPI/technology transfer; knowledge of cGMP/GLP/regulatory requirements.
- Leadership in cross-functional teams; communication with senior/global teams; strong problem-solving; Microsoft Office.
Benefits/Compensation (if applicable)
- Salary range: $153,935.00–$199,210.00; may include bonus, long-term incentives, paid time off, and medical/dental/vision/life insurance.
Application
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).
Key Responsibilities
- Lead and manage multiple concurrent clinical/commercial NPI projects for aseptic fill/finish (biologics or small molecule), including equipment for clinical (Line 3 flex fill) and commercial fill lines (Line 1 & Line 2), plus labeling and packaging.
- Define product transfer scope, timelines, and demands from PNGC/PPSC endorsement through manufacturing and release.
- Ensure compliance with regulatory requirements, cGMPs, GLPs, safety, and relevant standards; facilitate gap assessments with SMEs.
- Develop comprehensive product transfer work plans with cross-functional teams (Technical Services, Packaging, QA/QC, Validation, Supply Chain, Regulatory/CMC, EHS, Finance, IT, Engineering).
- Oversee daily project team workflow; drive milestone execution (line trials, installation/debug/startup, ATC, PPQs, product runs/studies).
- Track critical tasks (procurement, documentation, studies) and escalate issues; provide filling/packaging process/equipment guidance.
- Represent La Verne cross-functional team in NPI meetings and lead project review meetings.
- Provide senior management reporting; solve moderately complex problems; exercise sound judgment; improve procedures/processes.
Basic Qualifications
- Bachelor’s + 8 years experience OR Master’s + 6 years OR Ph.D.
Preferred Qualifications
- 10+ years (BS/BA) or 6+ years (MS/MA/MBA) in pharma small molecule/biologics fill/finish/inspection/labeling/packaging.
- 5+ years as a project manager; experience leading complex NPI/technology transfer; knowledge of cGMP/GLP/regulatory requirements.
- Leadership in cross-functional teams; communication with senior/global teams; strong problem-solving; Microsoft Office.
Benefits/Compensation (if applicable)
- Salary range: $153,935.00–$199,210.00; may include bonus, long-term incentives, paid time off, and medical/dental/vision/life insurance.
Application
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).