Associate Director, CMC Project Management jobs in United States
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Legend Biotech · 5 days ago

Associate Director, CMC Project Management

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. They are seeking an Associate Director for CMC Project Management to lead drug development activities for clinical pipeline programs, ensuring projects adhere to scope, budget, and timelines while fostering collaboration across teams.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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H1B Sponsor Likelynote
Hiring Manager
Justin Kerno
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Responsibilities

Ensure that projects/deliverables adhere to program and business goals by developing and driving project plans, capturing assumptions, managing cross-functional teams, and coordinating activities within the established project timelines set forth by the Technical Program Lead and/or project team
Integrate timelines and strategies across functions, identifying and addressing interdependencies
Support scenario planning and identification of acceleration opportunities
Monitor project progress continuously and make scheduled reports on measurable items, such as milestones and deliverables
Identify and track risks and ensure mitigation strategies are captured and implemented
Communicate proactively with all involved personnel to provide encouragement, identify problems, create solutions, and implement efficiency improvements
Contribute to regular program reviews (project/portfolio reviews, program strategy meetings, program risk management meetings) to accelerate program advancement, identify early critical success factors, and mitigate program risk
Drive CMC development strategies, activities, and timelines with responsible teams (process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/operational plans
Contribute to the creation integrated project budget and resource plan in partnership with Technical Program Lead and/or functional line representatives
Responsible for ensuring effective, accurate and timely communication of project information (meetings, minutes, action items) and coordinates interfaces with other departments
Hold functional teams accountable for committed objectives and timelines
Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective

Qualification

CMC drug developmentBiopharmaceutical experienceProject managementPMP certificationCell/Gene Therapy experienceRegulatory knowledgeAnalytical skillsSoftware proficiencyInterpersonal skillsProblem-solving skillsCommunication skillsCollaboration skillsOrganizational skillsNegotiation skills

Required

Bachelor's and/or MS degree in scientific discipline or related field required
7-10+ years of experience managing and leading projects/programs within the biopharmaceutical industry with strong participation in project teams
Demonstrated success in leading and negotiating in a matrix-based organization
Strong track-record in executing effective project management in cross-functional teams such as process development, clinical, regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry
Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management to teams
Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective
Superior interpersonal skills, communication skills and ability to manage conflicts and negotiations while providing impact and influence
Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
Strong organizational, analytical, and problem-solving skills
Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
Familiarity with project management software such as MS project, Smartsheet, think cell
Work independently to manage multiple projects simultaneously, making decisions and adjustments as necessary to meet deadlines and goals

Preferred

PMP certification
Cell/Gene Therapy experience
Expertise in CMC drug development pertinent to cell/gene therapy manufacturing
Knowledge of regulatory guidelines and/or regulatory experience

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

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Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.

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 Company
Total Funding
$750.45M
2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO

Leadership Team

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Carlos Santos
Chief Financial Officer
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Alan Bash
President, CARVYKTI
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Company data provided by crunchbase