Contamination Program Lead

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 a Contamination Program Lead as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Contamination Program Lead will be responsible for creating and maintaining the contamination control strategy program for the Cell Therapy facility following necessary FDA / Annex 1 requirements. This person will be the lead for contamination program, working cross functionally with various departments to ensure equipment and facility can be proper disinfected / maintained in an environmental state of control. This role will require microbial and engineering technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups. This individual will be an integral part of the CAR-T Environmental Monitoring Immediate Action team and Contamination Rapid Response Team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.

Key Responsibilities  

• The Contamination Program Lead will establish and maintain the program / strategy for the site.
• The role is responsible for ensuring the program aligns across sites in the network and responsible for presenting the strategy in health authority inspections.
• Assess change controls, risk assessment, trend reports and SOPs/Work Instructions for contamination impact.
• Support significant Environmental Monitoring and Sterility related investigations
• Support Facility expansion activities including having a robust contamination approach and integration with the existing facility.
• Support training of new and existing employees on the rational for proper contamination / disinfecting of equipment/personnel.

• Bachelor’s Degree – Preferably in Engineering or Microbiology
• Greater than 8 years of experience in Technical, Engineering, and/or Operations in a GMP production environment
• Experience conducting, supporting, reviewing and approving cleaning efficacy studies
• Experience in biotechnology or Cell Therapy preferred
• Experience with GMP equipment
• Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
• Strong organizational skills.
• Strong microbial background and in-depth knowledge of cleaning / sanitizing agent and their impact on process, equipment and consumables
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively.
• Experience with relevant regulatory requirements including in EU GMP Annex 1 inclusive of practical application.
• Strong understanding of regulatory and compliance requirements
• Excellent oral and written communication skills
• Highly collaborative and inclusive
• Ability to influence others to drive decision making
• Ability to effectively mentor and coach junior team members
• Language: English
• Must be willing to work a hybrid schedule: (At least 3-4 days on site per week)

#Li-Hybrid

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The anticipated base pay range for this is: $123,605 - $169,958 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.