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.
Requirements
- 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 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)
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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 law.
Legend Biotech maintains a drug-free workplace.