Supervisor, QC Microbiology

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Legend Biotech seeks a Supervisor, QC Microbiology to lead the operation and workflow of the QC microbiology laboratories in support of cell therapy manufacturing in Raritan, NJ. The role includes hiring, staff development, and ownership of laboratory data review along with method development and regulatory compliance.

The ideal candidate has a Bachelor's in Science/Engineering, 6+ years in the field (including leadership), and strong knowledge of cGMP, QA systems, and laboratory investigations.

Qualifications

• Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• Minimum of 6 years relevant work experience; aseptic manufacturing facility experience preferred.
• At least 1 year of leadership experience is required.
• Experience with Quality systems, cGMP regulations and FDA/EU guidance is required.
• Experience with clinical quality, method development, cell therapy, or R&D is preferred.

Responsibilities

• Provide training (skills-based, cGMP and safety) for associates within the department.
• Oversee raw material, in-process, environmental/utility, and product release testing.
• Schedule daily activities for personnel and manage workload.
• Investigate laboratory non-conformances (events, deviations, invalid assays).
• Maintain calibration and qualification of laboratory instruments/equipment.
• Lead test method verification, qualification, validation and transfer activities in QC laboratories.
• Support Process Performance Qualification and Continued Process Verification activities.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.

Skills

Leadership

GMP knowledge

Analytical skills

Communication

Education

Bachelor's Degree in Science/Engineering

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Supervisor, QC Microbiology as part of the Quality Operations team based in Raritan, NJ.

Role Overview

The Supervisor, QC Micro is an exempt level position with responsibilities for supervising theoperation and workflow of the quality control microbiology laboratories in support of cell therapy
manufacturing. This includes hiring, development and performance management of staff,reviewing/approving laboratory test data, developing and implementing microbiology procedures andmethods, supporting laboratory investigations and ownership of various QC microbiology departmentprojects.

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of associates within thedepartment.
• Raw material, in-process, environmental/utility, and product release testing.
• Scheduling of daily activities for personnel.
• Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QClaboratories.
• Process Performance Qualification and Continued Process Verification activities associatedwith QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering andMaintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance,Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
  

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.

• A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.

• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.

• People management or leadership experience is required.

• Experience working with Quality systems is required.

• Experience with quality support in clinical manufacture or NPI is preferred.

• Extensive knowledge of chemical, biochemical and microbiological concepts is required.

• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.

• Knowledge of cGMP regulations and FDA/EU guidance is required.

• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.

• Comfortable with speaking and interacting with inspectors.

• Good written and verbal communication skills are required.

• This position may require occasional travel to partner sites in NJ or PA as business demands.

• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review:Legend Biotech Privacy Notice.