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Vector Pipeline External Manufacturing Expert

Somerset, New Jersey, United States

Legend Biotech is seeking a Vector Pipeline External Manufacturing Expert as part of the Technical Development team based in Somerset, NJ. 

Role Overview

This position will be responsible for supporting viral vector clinical GMP manufacturing for Legend’s gene and cell therapy clinical pipeline. Reporting to the Associate Director of Viral Vector Sciences within the Technical Development team, this role will work closely with GMP manufacturing currently at external CDMOs and internal cross-functional teams, including analytical, quality, development, and regulatory leads, to deliver required retroviral and lentiviral vector material for ex vivo and in vivo programs. The successful candidate will be a collaborative and flexible individual with a combination of CDMO management, external manufacturing, MSAT, viral vector, and quality experience.

Key Responsibilities  

  • Support supplier/CDMO deviations, change controls, and tech transfers.
  • Support GMP batch release and batch record review activities with quality partners.
  • Collaborate with quality and regulatory functions to ensure GMP practices are followed by external partners and implement appropriate controls.
  • Author and review technical documents, protocols, and reports, including regulatory filings.
  • Support production of lentivirus and retrovirus at pilot, engineering, and GMP production scale for use in clinical cell and gene therapy project activities
  • Assist with testing and process changes, the evaluation of new offered technologies or capabilities, and provide support to CDMOs during execution of project activities.
  • Coordinate and align process, assays, and materials across multiple CDMOs and internal development activities.
  • Act as point of contact and conduct technical discussions & meetings with internal and external stakeholders.
  • Assist with streamlining systems and process flows for external change management.
  • Troubleshoot viral vector production process and analytical issues.
  • Proactively identify and communicate progress, delays, issues, risks and weaknesses to internal and external stakeholders.
  • Travel required as necessary, potentially international as well as domestic.

Requirements

  • BS/MS/PhD (or relevant experience) in related sciences or engineering preferred.
  • 7-15 years of relevant experience in viral vector development/MSAT, Quality and/or GMP production.
  • Prior GMP, MSAT, and/or tech transfer experience.
  • Knowledge of cGLP/cGMP guidelines.
  • Detail-oriented, excellent organizational skills with expertise in problem solving and solid decision-making abilities.
  • Excellent written and verbal communication skills are essential.
  • Experience working with CDMOs and within external manufacturing.
  • Experience authoring regulatory documents.
  • Expertise in suspension lentiviral and/or retroviral vector process development, manufacturing, and release testing.
  • Hands-on experience or high familiarity with common upstream and downstream unit operations.
  • Understanding of health authority regulations related to viral vectors is a plus.
  • Understanding of molecular biology, viral vectors, and viral vector-based assays is a plus.
  • Experience with in vivo LVV/RVV gene therapy is a plus.
  • Experience with plasmid and RNP manufacturing and testing is a plus.
  • General project management experience including tracking material demand/supply and drafting timelines is a plus.
  • Languages: English, Mandarin is a plus

#Li-JR1

#Li-Hybrid

The anticipated base pay range for this is: $142,146 - $195,452 USD. 

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.

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