Full-Time

CQV Specialist I

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Entry, Junior

Bridgewater Township, NJ, USA

Onsite presence required.

Category
Biology Lab & Research
Biology & Biotech
Requirements
  • A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
  • A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
  • Strong interpersonal and written/oral communication skills.
  • Ability to quickly process complex information and often make critical decisions with limited information.
  • 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 others in a team environment.
  • 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.
  • Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
  • Experience with TrackWise, Comet, CMMS, Veeva, and Maximo
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
  • Kneat, Kay, AVS/Validator
  • Language: English
Responsibilities
  • Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
  • Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
  • Supports and/or owns technical and quality investigations, CAPAs and corrections
  • Develops and performs any required remediation efforts and associated CAPA plans
  • Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
  • Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
  • Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
  • Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning

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 within 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

$146.4M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

20%

1 year growth

47%

2 year growth

106%
Simplify Jobs

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.

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