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Full-Time

Global Process Steward

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Hardware
Biotechnology

Senior, Expert

Bridgewater Township, NJ, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field.
  • Minimum 8 years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
  • Extensive experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
  • Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
  • Experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy
  • Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits
  • Experience in implementing and managing commercial process improvements and changes
  • Experience in driving consistency across multiple manufacturing sites.
  • Experience in collaborating with external partners and CMOs preferred
  • Extensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations support.
  • Ability to think critically and demonstrated troubleshooting and problem-solving skills.
  • Results driven with strong analytical, problem solving and critical thinking skills.
  • Strong experience working in a cross-functional organization with multiple partners with competing priorities.
  • Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.
Responsibilities
  • Represent MSAT at joint technical and CMC committees
  • Partner closely with senior Janssen technical team to achieve global alignment on all technical Carvykti scope
  • Provide technical direction and support of an expanding global manufacturing network for best-in-class CAR-T product.
  • Work collaboratively with internal and external partners to drive global process platform improvements and cost reduction initiatives
  • Drive strategy across multiple disciplines and functions to implement process changes / improvements, increase robustness, drive down OOS rates and improve delivery times to patients
  • Ensure global alignment on process platform parameters, unit operations and analytical methods at both internal and external CMO sites for both cell and vector processes
  • Ensure global records are consistent and maintained to achieve consistent performance worldwide for both Legend and partner sites.
  • Provide technical support and leadership during Agency Inspections, filing of Submissions, and IRs.
  • Maintain global master batch record and documentation on the platform process description and collaborate to the global change control process and global investigations.

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

38%

2 year growth

95%
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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.