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Full-Time

Associate Director of Quality Project Management and Strategy

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Senior, Expert

Bridgewater Township, NJ, USA

Category
Project Management
Business & Strategy
Required Skills
Communications
PowerPoint/Keynote/Slides
Requirements
  • Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
  • Experience: A minimum of 12-14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Lean Six Sigma Certification is a plus.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Advanced Therapy Manufacturing Practices(ATMPs).
  • Strong interpersonal and written/oral communication skills.
  • Ability to quickly process complex information and often make critical decisions with limited information.
  • Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
  • Proficient in applying process excellence tools and methodologies.
  • Ability to independently be responsible for a portfolio of ongoing projects.
  • Ability to pay attention to details and follow the procedures.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Good written and verbal communication skills are required.
  • Ability to summarize and present results, and experience with team-based collaborations is a requirement.
  • Ability to work with and lead others in a team environment.
  • Experience developing and setting long-term objectives.
  • Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
  • Ability to identify/remediate gaps in processes or systems
  • Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
  • Language Requirements: English
  • Travel Requirements: Potentially up to 5%
Responsibilities
  • Support and lead continuous improvement projects.
  • Managing people to support Quality improvement initiatives.
  • Provide quality and compliance input for site CI and remediation efforts.
  • Schedule and manage Quality tasks associated with process improvements.
  • Act as liaison for quality in support of site improvement projects and strategies.
  • Support and maintain site Quality metrics / Site Quality Cascade.
  • Collaborates with functional departments to resolve issues.
  • Support drafting of standard operating procedures, change controls and other documentation.
  • Manage cross-functional projects with many stakeholders.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
  • Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
  • Drive continuous improvement.
  • Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

Legend Biotech develops and sells cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's own cells to combat cancer. Unlike many competitors, Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments. Their goal is to provide effective treatments for hard-to-treat diseases through innovative cell therapy solutions.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

17%

1 year growth

41%

2 year growth

96%
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Simplify's Take

What believers are saying

  • Legend Biotech's recent European Commission approval for CARVYKTI® positions it as a leader in the multiple myeloma treatment market.
  • Strategic partnerships, such as the one with MaxCyte, enhance Legend Biotech's capabilities in cell engineering and expand its technological reach.
  • The company's commitment to transparency and investor relations, demonstrated through regular financial updates, fosters investor confidence and long-term stability.

What critics are saying

  • The competitive landscape in cell therapy and personalized medicine is intense, requiring continuous innovation to maintain market position.
  • Regulatory hurdles and the need for extensive clinical trials can delay the commercialization of new therapies, impacting revenue streams.

What makes Legend Biotech unique

  • Legend Biotech's technology-agnostic approach allows it to explore multiple innovative therapies, unlike competitors who may focus on a single technology.
  • The company's comprehensive business model, from discovery to commercialization, ensures control over the entire treatment lifecycle, providing a competitive edge.
  • Legend Biotech's strong focus on CAR-T therapies, particularly for hematological malignancies and solid tumors, sets it apart in the personalized medicine sector.