Supervisor, QC Microbiology

Legend Biotech, Inc.; Raritan (NJ); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Legend Biotech is seeking a Supervisor, QC Microbiology to support cell therapy manufacturing within Quality Operations in Raritan, NJ. You will supervise microbiology lab workflows, ensure cGMP compliance, and support microbiological testing for raw materials, in-process, environmental, and product release.

The role requires leadership, strong communication, and collaboration with QA, Manufacturing, Engineering, and Technical Operations to maintain compliance and advance biologics production.

Competenze

• Bachelor's degree in Science or related field.
• 6+ years in microbiology/QC, preferably aseptic or cell therapy.
• Minimum 1 year of leadership experience.
• Solid knowledge of microbiological principles, cGMP, and regulatory guidelines (FDA/EU).
• Preferred: experience in clinical quality, method development, cell banking, or R&D.

Mansioni

• Supervise microbiology laboratory workflows.
• Staff training and equipment maintenance.
• Investigations of non-conformances and QC strategy support.

Conoscenze

Microbiology

cGMP

Regulatory guidelines

Leadership

Staff training

Cell therapy knowledge

Formazione

BSc or related field

Strumenti

Lab equipment

Method validation

Descrizione del lavoro

Role: Supervisor, QC Microbiology supporting cell therapy manufacturing within Legend Biotech's Quality Operations in Raritan, NJ. Primary objectives include supervising microbiology laboratory workflows, ensuring compliance with cGMP, and supporting microbiological testing for raw materials, in-process, environmental, and product release.

Responsibilities

Responsibilities encompass staff training, equipment maintenance, test method validation, investigations of non-conformances, and contributing to QC strategy aligned with regulatory standards.

Requirements

Bachelor's in Science or related field; 6+ years in microbiology/QC, preferably in aseptic or cell therapy settings; minimum 1 year of leadership experience; solid knowledge of microbiological principles, cGMP, and regulatory guidelines (FDA/EU). Preferred: experience in clinical quality, method development, cell banking, or R&D. High-value biopharma specifics include expertise in cell therapy (autologous/allogeneic), GMP compliance, and involvement in QC microbiology supporting innovative biologics manufacturing. Collaboration spans Quality Assurance, Manufacturing, Engineering, and Technical Operations.

Work setup is onsite with occasional travel to partner sites; flexibility for overtime as needed. The role demands excellent communication skills, organizational ability, and comfort interacting with inspectors, with a focus on maintaining compliance and supporting advanced cell therapy production.