Senior Project Manager, cGMP Facility Design & Construction

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in several marketed products that are benefitting millions of people, a pipeline of late-stage therapy candidates and robust patient access programs to ensure treatments and 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.

Senior Project Manager, cGMP Facility Design & Construction

Role and Responsibilities for Position:

This position is in the Corporate Engineering and Facilities Department located in Foster City, California, and reports to the Sr. Director of Project Management.

In this position, you will develop, implement, and oversee capital (construction) cGMP projects to support biopharmaceutical research, process development, and manufacturing. Duties include leading and interfacing cross-functionally with internal teams, groups, departments, and external suppliers to ensure projects are delivered on time and within budget. This position will utilize a breadth of experience in construction, engineering, and cGMP quality to ensure facility regulatory compliance and effective project execution. The ideal candidate must be passionate about the work, detail-oriented, analytical, and have excellent problem-solving abilities. You’ll drive towards simple, scalable solutions to difficult problems, exercise project management skills, and be able to communicate complex analytical results in a clear and easy-to-understand manner. The candidate must be comfortable working in a fast-paced environment; able to adapt to change quickly and positively; deal effectively with a variety of people and situations; appropriately adapt thinking or approach as the situation changes

Required Competencies: Knowledge, Skills, and Abilities

• Strong project management skills and proven experience in managing medium to large capital projects (>$50M) with an emphasis on biopharmaceutical cleanroom manufacturing facilities and development laboratories in a cGxP/Annex 1 environment.
• Experience in end-to-end project delivery in a cGxP environment (initiation, planning, design, construction, validation, and turnover process).
• Solid understanding of cGMP manufacturing facility and GMP Annex 1 standards and clean room environmental standards. Knowledge of critical building utility systems such as HVAC, compressed air/gases, WFI, RODI, vacuum, and waste, as well as security systems and policies.
• Possesses broad knowledge of the functional requirements of biologics facilities and engineering best practices, while ensuring that appropriate internal and external resources are incorporated into the project design and execution.
• Experience implementing Commissioning, Qualification, and Validation (CQV) processes and integration of the GAMP5 V-model throughout the project design process.
• Project Management skills include the development and management of work breakdown structures, schedules, budgets, risk identification and management, and change management.
• Proven ability to facilitate project governance meetings with stakeholders and management team and address key issues, risks, and decisions.
• Understanding of city permitting process, building codes, and OSHA regulations as it relates to engineering and facilities construction.
• Strong budget/financial management skills relating to CapEx and OpEx spending and project cash flow forecasting.
• Proficient with project management tools to identify problems and deficiencies and manage risk.
• Exhibits project leadership and effective decision-making throughout each project. Leads and promotes effective teamwork by engaging EH&S, Facilities, Technical Engineering, Space Planning, Security, users, area owners, and other key stakeholders.
• Ability to read and understand engineering specifications, Architectural, MEP, and P&ID Drawings.
• Solid understanding of building systems, codes, and ADA requirements as it relates to construction.
• Understand, interpret, and apply laws, rules, regulations, policies, procedures, contracts, budgets, and labor management agreements.
• Proficient with construction terminology and legal content of construction contracts, documents, and logistics.
• In-depth knowledge of construction project delivery approaches (e.g., design-bid-build, design-assist, design-build, IPD) and types of contracts (e.g., GMP, Lump Sum, Incentive).
• Demonstrates a solid understanding of industry-known project management delivery process and proficient with project management Stage-Gate process.
• Monitor and apply performance management techniques. Oversee cost estimating, budgeting, cost management, and controls, scheduling, and reporting.
• The interface between budget and reporting tools to support management tracking, reporting, and stage-gate decision-making.
• Contribute to the development of high-performance teams through rigorous goal-setting, disciplined attention to performance metrics, and continuous process improvements.
• Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent communication skills, excellent writing skills, and organized analytical thinker with a high level of energy and self-motivation.
• Must be able to work on highly complex problems in a variety of situations where analysis is required. Solve problems using considerable and rational judgment, leading to specific recommendations.
• Must be a team player with sufficient experience working in multiple cross-functional teams and in leading discussions.
• Proficient at collecting, analyzing, and understanding data. Use of techniques and methods to present data in a format that promotes effective and evidence-based managerial decision-making.
• Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of Gilead’s Core Values.
• Demonstrated ability to work as an individual contributor in dynamic team environments.

Preferred Qualifications

• Minimum 9 years of direct experience working in the U.S. construction industry with a B.A./B.S. degree OR 7 years of direct experience with an M.S./M.A. degree in Engineering (e.g., Mechanical, Electrical, Civil, Chemical, Process, Plumbing, Automation and Control) or related discipline.
• Solid knowledge base in cGMP and/or GMP Annex 1, with direct experience in managing and executing Cx and validation (e.g., manufacturing facility IOQ, PQ).
• Proficient with tools required to create and present high-quality written and graphic deliverables, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint), and MS Project.
• Proficiency in creating reports and presentation slide decks using MS PowerPoint, and business intelligence tools such as Tableau or Power BI.
• Training and direct experience in cGxP quality compliance such as identifying, writing, and processing deviations, investigations, and CAPAs using electronic document management systems.

Education, Skills and Experience:

• Bachelor’s degree in Engineering (or related technical discipline) with a minimum 12 years of experience directly managing large capital projects in the life science (Biotech, Pharmaceutical) industry, or 10 years of direct experience with an M.S. degree in Engineering
• Education or experience in process engineering or clinical manufacturing is preferred
• Proficient with tools required to create and present high-quality written and graphic deliverables, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint), and MS Project
• Proficiency in creating reports and presentation slide decks using MS PowerPoint, Thinkcell, Timeline, and business intelligence tools such as Tableau or Power BI
• Proficiency in CPM scheduling method such as MS Project or Primavera P6
• Experience working within construction management platforms (e.g., Procore, eBuilder)
• Knowledge of site master planning, LRP, and budget estimation and forecasts
• PMP certification and experience in agile and/or lean project management methodology is preferred
• Experience in managing direct reports including coaching, mentoring, conflict resolution, providing feedback, goal setting using SMART approach, and conducting formal reviews

Job Requirements:

Job Type:

Full-time, on-site 100% of the time due to the nature of work GFlex is unavailable.

Work Location:

CA - Foster City

Physical requirements:

Candidate must be comfortable working in construction sites wearing required PPE and must be able to lift up to 25 lbs. Must be able to climb ladders or stairs. Must be able to visually inspect construction job site routinely and compare against target milestones.

Travel Requirements:

Up to 10% or as needed to oversee occasional projects outside of Foste