Full-Time

Global Process Steward

Posted on 7/26/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Senior

Bridgewater Township, NJ, USA

Hybrid position requiring in-office presence.

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 commercializes 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 cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Company Stage

IPO

Total Funding

$146.4M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.
  • New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.
  • Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

What critics are saying

  • Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.
  • Collaboration with Multiply Labs may face technological challenges, delaying production timelines.
  • Financial strain from new R&D facility could affect operational focus if advancements lag.

What makes Legend Biotech unique

  • Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.
  • The company is technology agnostic, exploring multiple platforms for effective cancer treatments.
  • Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

INACTIVE