Sr Manager- Project Management NPI

Sr Manager- Project Management – NPI

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987.With the commitment and drive you bring to our workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

We are seeking a highly motivated individual to join us as a Sr. Project Manager to work at our Oceanside Biologics development and clinical manufacturing site in Oceanside, CA. This position will work with other project managers to drive drug development programs, projects, goals and initiatives in a dynamic and fast paced organization.

The NPI Project Manager will be responsible for the successful initiation, planning, execution, monitoring, controlling and closure of multiple New Product Introduction projects through to production in our clinical manufacturing facility. You will work in close collaboration with all departments at the site and will also partner with CMC Project Management, Outsourcing, and other corporate and external functions, as needed to support development projects. In addition, this role will serve as a thought partner to our technical operations organizations to drive improvements and sustainability of our tech transfer processes, tools, and systems. This position will report to the Oceanside PMO Director.

The Oceanside PMO is accountable for providing project management support for all site activities, including Project and Portfolio Management, Contracts Management, Business Analytics, Site Strategy, and Site Communications. As a member of the Oceanside PMO department this role will serve as the bridge between the Biologics Clinical Technical Operations functions and the rest of the site.

Job Responsibilities

• Provide PM support to the Biologics Technical Operations functions and their governance processes and workflows.
• Develop and maintain project scope and timelines for New Product Introduction activities to transfer drug substance manufacturing processes from Biologics development or external partners into our clinical facility in Oceanside.
• Manage multiple technical transfers and other projects simultaneously
• Utilize Project Management Methodology in alignment with internal PMO guidelines to develop high-level and detailed schedules and drive pre- and post-tech transfer activities and collaboration.
• Work with cross-functional teams, track project status, perform risk identification and mitigation, and ensure timely and effective escalations per established process when key decisions or input is needed from senior leadership.
• Manage Lessons Learned workflow for tech transfer processes to drive continuous improvement.
• Partner with Tech Ops and other key receiving site stakeholders such as Quality Assurance, Quality Control, Manufacturing, etc.to develop and improve Technology Transfer business processes to enable right-first-time and efficient transfers.
• Support authoring of project plans, schedules, communication materials and relevant project documentation
• Establish strong working relationships across departments, with key stakeholders and senior management to facilitate effective communication and transparency.
• Foster a team culture of accountability by setting agendas, directing collaborative and efficient discussions and establishing agreement on a clear path to success.
• Contribute towards sustainability of project management processes, tools and systems.
• Represent site PMO in meetings and forums

Knowledge, Experience and Skills:

• Bachelor's degree in Biology, Chemistry or related field and 8+ years of relevant experience or
• Master's degree and 6+ years of relevant experience
• Knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/cell therapies is a plus.
• Relevant experience managing tech transfer activities in biotech environment is required
• Background in Operations or Process Development is required
• Relevant experience managing technical cross-functional activities in a scientific setting.
• Able to think critically and demonstrate troubleshooting and problem-solving skills.
• Excellent written, analytical, and oral communication skills
• Strong interpersonal skills with ability to work effectively across matrix teams
• Proficiency in Microsoft Office Suite (Outlook, Word, PowerPoint, etc.) and Microsoft Project and/or Smartsheet is required.
• Smartsheet project management tool expertise a plus
• Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations, difficult conversations, and ambiguous assignments.
• Skilful at building trust and team cohesion, with demonstrated track record of driving and leading teams, and influencing colleagues at all levels of the organization.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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