Senior Manager, Project Management New Product Line Manufacturing - Labeling

Gilead SciencesLa Verne, CA
244d$153,935 - $199,210

About The Position

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 fulfill their aspirations. Join Gilead and help create possible, together.

Requirements

  • Bachelor's Degree and Eight Years' Experience OR Master's 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.
  • 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 ongoing and completed initiatives. Collaborate with senior leadership for key decision-making.
  • Tackle moderately complex problems by using 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.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives (eligibility may vary based on role).
  • Paid time off.
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