Sr. Advanced Specialist Clinical Manufacturing Operations and Sciences, Viral Vector

Legend Biotech is seeking a Sr. Advanced Specialist Clinical Manufacturing Operations and Sciences, Viral Vector as part of the Technical Development team based in Somerset, NJ
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The Sr. Advanced Specialist Clinical Manufacturing Operations and Sciences, Viral Vector will be responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering Phase 1 clinical trial material for several viral vector pipeline assets to patients in need. The successful candidate will collaborate with a cross-functional team including quality, IT, facilities, safety, and operations to establish the systems necessary to operate a GMP manufacturing facility for the purpose of producing Phase 1 products.

The following activities will include tech transfer, data analysis, troubleshooting and executing manufacturing viral vector product candidates within the facility.

• Create and author manufacturing procedures necessary to operate a viral vector suite within a GMP manufacturing facility at Phase 1 clinical standards.
• Author facility risk and gap assessments for implementation of GMP viral vector manufacturing.
• Collaborate with Technical Development teams to identify GMP viral vector manufacturing equipment.
• Act as the primary manufacturing point of contact for study, and clinical manufacturing execution escalations for multiple viral vector GMP processes.
• Provide manufacturing oversight, training, and support within the manufacturing cleanroom environment.
• Drive Technology Transfer campaigns of new product introduction and process improvements to internal programs.
• Provide hands-on manufacturing training as needed.
• Translate process development reports into manufacturing batch records and SOPs as part of tech transfer.
• Analyze and interpret manufacturing process data.
• Perform complex manufacturing investigations including OOS, OOT, and deviations.
• Author and review investigation reports, CAPAs, and change controls.
• Review and resolve corrections in executed batch records.
• Review executed batch records and assist with corrections as required.
• Drive continuous improvement initiatives.
• Represent viral vector manufacturing operations as technical SME in cross-functional meetings and project teams, providing subject matter expertise minimally on manufacturing operations, execution trends, and manufacturing requirements.
• Coordinate with QC to transfer samples for testing and support the investigate out-of-specification results collaboratively.
• Author and lead execution of tech transfer protocols.
• Foster a culture of quality and compliance.

• BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
• 5+ years of experience in viral vector GMP manufacturing including operations, supervision, tech transfer, and strategy setting.
• Knowledge and experience with viral vector manufacturing and tech transfer.
• Experience establishing and operating in a GMP environment.
• Experience and knowledge of viral vector manufacturing equipment.
• Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient.
• Experience working in cross-functional matrices.
• Excellent collaboration skills.
• Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
• Expertise with aseptic processing.
• Patient focus is a must.

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.

Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Please note:
These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability,…