Senior Manager, Tech Transfer Project Management

Gilead Sciences•La Verne, CA

4d•$153,935 - $199,210•Onsite

About The Position

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 (fill/finish) areas and equipment purposed for the clinical flex fill line (Line 3) and commercial fill lines (Line 1 and Line 2). 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 internal customer expectations. This position is onsite daily in La Verne, CA, relocation is not offered therefore local candidates are encouraged to apply.

Requirements

Bachelor's Degree and Eight Years’ Experience OR Masters' Degree and Six Years’ Experience OR Ph.D.
8+ years of relevant experience in pharmaceutical industry with a focus on inspection/packaging and a sciences BS/BA degree.
6+ years of relevant experience in pharmaceutical industry with a focus on inspection/packaging and a MS, MA or MBA.
3+ years successfully serving as a project manager.
Proven experience in managing complex NPI or technology transfer projects.
Knowledge of cGMPs, GLPs, and regulatory requirements in a manufacturing setting.
Demonstrated leadership ability in cross-functional teams, including Technical Services, Manufacturing/Packaging, QA, QC, Validation, Supply Chain, and Engineering.
Excellent communication skills, with experience interfacing with senior management and cross-functional global teams.
Strong problem-solving and decision-making skills, with a focus on driving project success in a fast-paced environment.
Proficient in Microsoft Office applications.

Responsibilities

Lead and manage multiple, concurrent clinical and commercial NPI projects impacting the inspection 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.
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.
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.
Oversee and manage daily workflow of the project team, ensuring that milestones are met and any potential risks or delays are proactively addressed.
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.
Utilize knowledge in inspection and packaging processes and equipment to provide guidance and support for global, cross-functional discussions, ensuring alignment of decisions to meet project objectives.
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.
Lead regular project review meetings with cross-functional representatives, ensuring projects are on track and addressing any deviations promptly.
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.
Tackle moderately complex problems by applying creative problem-solving techniques and offering innovative recommendations to drive project success.
Exercise sound judgment in selecting appropriate methods, techniques, and evaluation criteria to achieve project goals while adhering to defined practices and policies.
Provide tactical guidance and management to the project team, ensuring alignment with broader Packaging Operations objectives and strategies.
Contribute to the development and implementation of standardized procedures and processes to ensure consistency in Packaging Project Management.
Play a key role in the creation of new concepts, techniques, and operational standards.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.