Legend Biotech · 4 hours ago
Associate Operations Specialist
Raritan, New Jersey, United States
Full-time
Onsite
Entry Level
$71K/yr - $93K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are seeking an Associate Operations Specialist to provide operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant, ensuring compliance and efficiency in personalized cell therapy production.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Provides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support Labs
Collaborates with Technical Operations who are responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data management
Partners with Operational Excellence to implement improvements
Writes, reviews, owns and updates SOPs
Owns, provides assessments and takes actions in support of change controls
Owns CAPAs and associated project plans
Supports events such as Root Cause Analysis (RCAs) and FMEAs
Participates in kaizens and other project initiatives
Supports any business improvement efforts
Supports permanent inspection readiness and actively supports internal audits and regulatory inspections
Qualification
Required
BS/BA required in technical discipline: Engineering, science or similar field
GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry
2+ years of experience leading and/or supporting improvement or remediation efforts
Strong understanding and proven application of problem solving tools and techniques
Demonstrated involvement in revision of SOPs, change controls, investigations, CAPAs and other quality system actions
Ability to engage all levels of the organization, from site leadership to the shop floor
Proven experience working and leading in a matrix environment
Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Strong ownership skills and ability to work independently
Strong analytical, problem solving and critical thinking skills
Excellent organizational and communication skills
An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures
Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products
Physical dexterity sufficient to use computers and documentation
Solution-oriented mentality, capable of developing new procedures and alternate paths to overcome identified opportunities for improvement
Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses
Color Perception both eyes 5 slides out of 8
Preferred
Cell/Gene Therapy cGMP manufacturing experience preferred
Lean Six Sigma Green desirable
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 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
Company data provided by crunchbase