Legend Biotech · 2 months ago
CQV Specialist II
Raritan, New Jersey, United States
Full-time
Onsite
Mid Level
$81K/yr - $107K/yr
4+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are seeking a CQV Specialist II to provide Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant, ensuring compliance and effective operations in cell therapy production.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
Supports and/or owns technical and quality investigations, CAPAs and corrections
Develops and performs any required remediation efforts and associated CAPA plans
Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning
Qualification
Required
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A minimum of 4 years relevant work experience is required
It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and often make critical decisions with limited information
Proficient in applying process excellence tools and methodologies
Ability to independently be responsible for a portfolio of ongoing projects
Ability to pay attention to details and follow the procedures
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
Good written and verbal communication skills are required
Ability to summarize and present results, and experience with team-based collaborations is a requirement
Ability to work with others in a team environment
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing
Ability to identify/remediate gaps in processes or systems
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required
Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols
Experience with TrackWise, CMMS and Maximo
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Language: English
Preferred
Experience with 600, 601, and 610 is 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 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
thefly.com
2025-12-09
Company data provided by crunchbase