Senior Manager, Tech Transfer Project Management

Responsibilities

• Program Management:
• Lead and manage multiple, concurrent clinical and commercial NPI projects impacting the fill/finish or inspection, labeling and packaging areas and equipment.
• Define and understand product transfer scope, timelines, and demands from PNGC or PPSC endorsement through manufacturing and release, coordinating resources from the La Verne site to meet objectives.
• Quality and Compliance Oversight:
• Ensure product transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Safety regulations, and other relevant standards.
• Facilitate necessary gap assessment with the SMEs from La Verne or from the global sites.
• Work Plan Development:
• Develop comprehensive work plans for each product transfer in collaboration with cross-functional teams, including Technical Services, Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/CMC, EHS, Finance, IT, and Engineering.
• Project Team Management:
• Oversee and manage daily workflow of the project team, ensuring that milestones are met and any potential risks or delays are proactively addressed.
• Milestones can be ranging from machine line trials, installation/debug/startup, Acceptance Testing and Commissioning (ATC), and PPQs (commercialization ready), and product runs/studies for any follow-up measures per the regulatory feedback/demands.
• Task Tracking and Escalation:
• Track the status and completion of critical tasks, such as procurement, documentation, and studies, to ensure milestones are achieved. Escalate issues when necessary to ensure timely resolution.
• Cross-Functional Guidance:
• Utilize knowledge in filling and packaging processes and equipment to provide guidance and support for global, cross-functional discussions, ensuring alignment of decisions to meet project objectives.
• Stakeholder Representation:
• Represent the La Verne cross-functional team in NPI-focused meetings with corporate stakeholders, facilitating communication and bridging any gaps in understanding between corporate and site personnel.
• Project Review and Leadership:
• Lead regular project review meetings with cross-functional representatives, ensuring projects are on track and addressing any deviations promptly.
• Senior Management Reporting:
• Provide regular and timely updates to senior management on the status of NPI projects, including upcoming, ongoing, and completed initiatives. Collaborate with senior leadership for key decision-making.
• Problem-Solving and Innovation:
• Tackle moderately complex problems by applying creative problem-solving techniques and offering i

Benefits

Additional Information

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 Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Gilead Sciences La Verne Engineering Project Management Office (PMO) is seeking a Senior Manager, Tech Transfer Project Management . We seek a highly motivated and knowledgeable, individual to lead New Product Introduction ( NPI ) efforts for the La Verne site aseptic manufacturing of biologics or small molecule (fill/finish) and equipment purposed for the clinical flex fill line (Line 3) and commercial fill lines (Line 1 and Line 2), Labeling and Packaging lines. This individual will work directly with, and coordinate activities for, key stakeholders from multiple departments and cross different sites (e.g. Foster City) to ensure NPI projects, ranging from pre-pivotal to pivotal clinical phases, are executed to meet the global product technical transfer timeline, clinical demands, and commercialization to meet internal customer expectations. This position is onsite daily in La Verne, CA , relocation is not offered therefore local candidates are encouraged to apply.

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