Operations Specialist at Legend Biotech

Raritan, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

99713.0

Posted On

19 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Manufacturing, Cell Therapy, Process Improvement, Problem Solving, SOP Management, Change Control, CAPA Management, Root Cause Analysis, Lean Principles, Analytical Skills, Communication Skills, Collaboration, Project Management, Regulatory Compliance, Aseptic Technique, Quality Systems

Industry

Biotechnology Research

Description

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Technical Operations in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for driving and implementing a wide variety of improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. Key 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. Provides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols. Provides input and supports improvements related to the aseptic environment and technique. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. 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. Requirements BS/BA required in technical discipline: Engineering, science or similar field. GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred. Fundamental understanding of Lean principles and tools, Lean Six Sigma Green desirable. 3+ years of experience leading and/or supporting improvement or remediation efforts. Strong understanding and proven application of problem solving tools and techniques. Demonstrated experience ownings 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. #Li-DD1 #Li-Onsite The anticipated base pay range is $75,972—$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating 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. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Responsibilities

The Operations Specialist will provide operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant, ensuring safe and compliant manufacturing operations. This role involves collaboration across various functional groups to drive improvements and support production, testing, and product release.