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Senior Project Manager, GMP Onsite

Semma Therapeutics

Semma Therapeutics

Operations
Boston, MA, USA
Posted on Saturday, April 13, 2024

Job Description

SENIOR PROJECT MANAGER, PMO:

The Senior Project Manager, Capital Project Management Office (PMO) is responsible for managing GXP related capital projects in the Global Operations and Real Estate project portfolio. The Sr. PM role will include managing a variety of projects at Vertex’s facilities, primarily projects at cGMP manufacturing facilities. This Sr. PM role will work closely with the Advanced Manufacturing Engineering (AME) team, supporting AME in their strategic partnership with CMC and Commercial teams in launching new/existing products at internal and external manufacturing sites. Additionally, the Senior Project Manager may also manage projects at other facilities in Vertex’s global real estate portfolio as needed. Project values could range from $50,000 to $100,000,000+ depending on candidate's experience and proficiency.

This is an onsite role.

Candidates should have a proven track record of successful project delivery and experience representing owners’ interests in the pharmaceutical industry, including GMP manufacturing and R&D labs. Additional experience managing facility infrastructure and office environment projects is welcome. Excellent communications, organization skills, and creativity in problem solving are required for success in this position. The candidate must be able to build and maintain strong, cross-functional relationships with key stakeholders and be a trusted team leader.

KEY RESPONSIBILITIES:

  • Define, plan and execute the full scope of assigned projects. Ability and willingness to perform project tasks at all levels to meet the project needs, from basic to complex, both independently and collaboratively

  • Identify, analyze, prioritize, communicate and mitigate project risks

  • Manage multiple projects simultaneously to successful outcomes

  • Forecast, track and manage project budgets, POs, and invoices in accordance with generally accepted accounting principles

  • Coordinate appropriate resources (technical & non-technical) to meet project needs

  • Assist AME in determining manufacturing scope and associated facility impacts

  • Create and maintain GMP project budget requiring cross-collaboration with multiple teams for budget generation and input.

  • Coordinate project commissioning, qualification, and validation (CQV) efforts in collaboration with the Global Engineering and CQV team(s), including IQ/OQ/PQ, and cleaning validation, as applicable

  • Review Engineering Turn Over Packages (ETOP) for accuracy and consistency with Vertex standards

  • Work collaboratively with user groups, Facilities, Manufacturing Operations, EH&S, Security, Global Engineering, Corporate Real Estate, Information Technology, Quality, Regulatory, and others

  • Plan and manage internal and external project communications, ensuring effective exchange of project information, expectations, and deliverables

  • Provide and promote high standards of professionalism, integrity and leadership, both within and outside the organization, appropriately representing Vertex Core Values, business philosophies, protocols and standards

  • Ability to travel domestically and internationally (approximately 5% of the work year). Most travel duration is three to five days in length.

TECHNICAL AND COMMUNICATION SKILLS:

  • Very strong project management skills throughout the entire capital project lifecycle, from concept to final design to ongoing facility support.

  • Knowledge of cGMP and regulated facility design, change control processes, compliance requirements, commissioning, qualification, and validation and best practices in the pharmaceutical industry.

  • Knowledge of general office and research facility design, including architectural elements, MEP systems, FF&E, specialty equipment, and energy reduction/sustainability initiatives

  • Advanced understanding of MEP systems and site engineering as it relates to GMP equipment, facility & utility impact(s).

  • Understand strategic decisions for capital projects based on evolving science and technology as it relates to potential facility and cost impacts.

  • Thorough understanding of construction contracts, construction logistics, and challenges associated executing construction activities in sensitive environments

  • Knowledge of estimating, budgeting, and scheduling processes, construction contract terms and conditions

  • Strong communication skills, including a demonstrated strength in effective writing and verbal communications, and the ability to energize team members to continue making progress at all stages of the project lifecycle

  • Strong time management skills and the ability to effectively manage multiple competing priorities and challenging deadlines

  • Computer skills include: MS Office suite, MS Project, MS Visio. Familiarity with Bluebeam, CAD, BIM/Revit and CMMS systems is recommended, but not required

EDUCATION AND EXPERIENCE:

Bachelor's Degree in Architecture, Civil, Electrical, Mechanical, Chemical Engineering or Construction Management or related field. 8+ years of total relevant experience, 5 years being direct experience working in GXP capital project manager role overseeing planning, design and construction processes; OR, Any equivalent combination of experience and/or education from which comparable knowledge, skills and abilities have been achieved.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.