Legend Biotech · 4 hours ago
MES Project Manager
Raritan, NJ
Full-time
Onsite
Senior Level
$93K/yr - $130K/yr
7+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The MES Project Manager will provide project management support for the development and administration of electronic batch records and digital solutions at the Raritan site, ensuring project deliverables are met on time and within budget.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Lead project core teams to ensure on time project delivery
Leads generation and alignment of MES and/or IT project plans across functional teams Defines the interdependent deliverables for MES and/or digital projects and ensures that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget
Drives milestone decision point planning and associated deliverables across functions to achieve the MES and/or digital project objectives
Clearly defines the critical path and generates clear decision criteria for the project
Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk, cost, time) to the project or program
Prepares and manages MES governance interactions in partnership with the Project Sponsor
Monitors and reports on progress of the MES and/or IT project goals
Manages an integrated project budget and resource plan in partnership with the Project Sponsors, Finance team member, and functional line representatives within the MES core team
Responsible for development and management of the communication plan for the MES / digital project, including stakeholder management
Responsible for ensuring effective, accurate and timely communication of project information
Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right first time EBR designs
Preference for candidates to have relevant experience supporting MES and/or digital enhancements within a GMP site
Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.)
Coordinate MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ)
Support defining standardizations and update documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures
Establish key stakeholder relationships with internal and external stakeholders
Ability to interact with all levels within the organization
Qualification
Required
A minimum of a Bachelor's degree in engineering or related field or equivalent experience required
A minimum of 7 years of relevant experience is required
Demonstrated experience translating business needs to system requirements and planning and leading multiple complex projects/programs within biopharmaceutical industry
Must have experience creating a highly collaborative and inclusive environment necessary for the team to be effective
Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry
Demonstrated results in creating and managing complex program plans
Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities
Ability to engage all levels of the organization, from site leadership to the shop floor
Accurately and reliably gauge task effort and plan work to meet project timelines
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing
An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
Preferred
Advanced degree and PMP certification strongly preferred
Cell/Gene Therapy cGMP manufacturing experience preferred
Having experience with global teams, budgetary management, resource planning, and fiscal awareness is preferred
Lean experience with practical application. Yellow belt certified a plus, green belt certified preferred
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
Company data provided by crunchbase