Legend Biotech USA
Associate Director, CMC Program Management
Philadelphia, PA
Mar 20, 2025
Full Job Description

Legend Biotech is seeking an Associate Director, CMC Program Management as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Technical Project Manager role will support/lead CMC drug development activities for clinical pipeline programs. The PM will be responsible for the coordination of technical projects, including successful planning and execution of CMC program deliverables as well as oversight throughout entire execution to ensure success as defined by adherence to standards of scope, budget, and timeline. This position will also be responsible for establishing and reporting on key project/program metrics in support of on-time and on-budget project deliverables. The role will require leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups.

Key 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.

Requirements

  • Bachelor's and/or MS degree in scientific discipline or related field required. PMP certification preferred.
  • 7-10+ years of experience managing and leading projects/programs within the biopharmaceutical industry with strong participation in project teams.
  • Cell/Gene Therapy experience preferred.
  • Expertise in CMC drug development pertinent to cell/gene therapy manufacturing preferred.
  • Knowledge of regulatory guidelines and/or regulatory experience preferred.
  • Demonstrated success in leading and negotiating in a matrix-based organization.
  • 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.

#Li-BZ1

#Li-Hybrid


Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

PDN-9e79672a-20bf-4b66-9452-1813ad35da69
Job Information
Job Category:
Other
Spotlight Employer
Related jobs
Novartis
Job Description SummaryCustomers may include, but are not limited to IDN Systems, Hospitals, Clinics, Directors of Pharmacy, Buyers, HCPs, Clinicians, Pharmacy & Therapeutic Committees, and other...
Mar 20, 2025
Position
Novartis
Job Description SummaryThis is a field-based and remote opportunity supporting key accounts in an assigned geography.Novartis is unable to offer relocation support for this role. Please only apply if...
Mar 20, 2025
Portland, ME
Novartis
Job Description SummaryThis is a field-based and remote opportunity supporting key accounts in an assigned geography.Novartis is unable to offer relocation support for this role. Please only apply if...
Mar 20, 2025
©2025 NAACP.
Powered by TalentAlly.
Apply for this job
Associate Director, CMC Program Management
Legend Biotech USA
Philadelphia, PA
Mar 20, 2025
Your Information
First Name *
Last Name *
Email Address *
This email belongs to another account. Please use a diferent email address or Sign In.
Zip Code *
Password *
Confirm Password *
Create your Profile from your Resume
By clicking the Apply button, you agree to the terms of use and privacy policy and consent to receive emails from us about job opportunities, career resources, and other relevant updates. You can unsubscribe at any time.
Continue to Apply

Legend Biotech USA would like you to finish the application on their website.

Supercharge Your Resume with AI

Boost your resume with AI-driven enhancements. The tool analyzes and refines your content, highlighting your strengths and tailoring it for maximum impact. Get personalized suggestions and apply improvements instantly to stand out in the job market.