Legend Biotech · 1 month ago
Clinical Manufacturing Operations and Sciences Sr. Advanced Specialist, Viral Vector
Somerset, New Jersey, United States
Full-time
Onsite
Mid, Senior Level
$107K/yr - $141K/yr
5+ years expLegend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. They are seeking a Clinical Manufacturing Operations and Sciences Sr. Advanced Specialist, Viral Vector to provide technical strategies and perform activities necessary for the operation of a new GMP facility and deliver clinical trial material for viral vector pipeline assets.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
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
Qualification
Required
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
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
Company data provided by crunchbase