Vector Pipeline External Manufacturing Expert

Legend Biotech is seeking a Vector Pipeline External Manufacturing Expert to join their Technical Development team. This role is crucial for supporting viral vector clinical GMP manufacturing for Legend Biotech's gene and cell therapy clinical pipeline. The expert will collaborate with external CDMOs and internal teams to ensure the delivery of retroviral and lentiviral vector material.

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.

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.

Benefits: