Legend Biotech · 19 hours ago
Validation Lifecycle & Technical Lead
United States
Full-time
Remote
Senior Level
5+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Validation Lifecycle & Technical Lead will support global process validation activities for the commercial Carvykti program, collaborating with cross-functional teams to establish best practices in validation and quality compliance.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub-teams to support global best practices
Partner closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templates
Work collaboratively with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
Align global documentation strategy
Provide input and review for validation documents including master plans, PPQ and comparability protocols and reports
Serve as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limits
Develop and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templates
Support global initiatives related to quality/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
Contribute to developing and/or improvements to quality systems in support of global implementation of changes (e.g., process and material changes)
Qualification
Required
B.S. required
Minimum 5 years of industrial biologics experience, CAR-T experience is highly desirable
Candidate must have experience in Cell Therapy, MSAT and/or Quality/Compliance (particularly in material/ raw material enrollment and release)
Experience in a cross functional commercial team in driving global programs and/or initiatives
Experience in developing, writing and approving technical documents
Experience with Quality systems (Change control, investigations, LIMs, etc.)
Extensive technical writing experience
Ability to think critically and demonstrated troubleshooting and problem-solving skills
Results driven with strong analytical, problem solving and critical thinking skills
Experience working in a cross-functional organization with multiple partners with competing priorities
Preferred
Knowledge in cell therapy validation industry best practices is highly preferred
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company 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
thefly.com
2025-12-09
Company data provided by crunchbase