Senior QC Microbiology Lead, Cell Therapy Ops

BioNJ Inc.; Raritan (NJ); Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

Legend Biotech in Raritan, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs in support of cell therapy manufacturing.

The role includes hiring, staff development, data review, and ownership of department projects. You will develop long-term strategies, manage a team of people leaders and professionals, and collaborate with QA, manufacturing, and maintenance to meet business objectives while ensuring compliance with cGMP and regulatory expectations.

Qualifications

• Bachelor's degree in Science, Biology or equivalent.
• 12–14 years of relevant work experience in aseptic manufacturing.
• 3–5 years of leadership experience in QC or cell therapy.
• Experience with Quality systems (FDA/EU guidance) and cGMP.
• Strong data analysis, problem-solving and communication skills.
• Willingness to travel up to 10%.

Responsabilités

• Oversee training and development of department staff in cGMP and safety.
• Manage testing across raw materials, in-process, environmental monitoring, release and stability.
• Lead investigations of lab non-conformances and deviations.
• Maintain and qualify lab instruments and equipment.
• Coordinate test method verification, validation and transfer.
• Drive Process Performance Qualification and Continued Process Verification.
• Provide troubleshooting and analytical leadership for complex lab issues.
• Ensure compliance with current pharmacopeia and regulatory guidelines.
• Collaborate with QA, Manufacturing, Technical Operations, Engineering and Maintenance.
• Assist in budgeting and resource planning for the QC microbiology group.
• Support audits and represent the department.

Connaissances

Leadership

Quality systems

cGMP regulations

Data analysis

Communication

Problem solving

Formation

Bachelor's degree in Science / Biology

Outils

Laboratory instruments

Description du poste

Legend Biotech in Raritan, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs in support of cell therapy manufacturing.

The role includes hiring, staff development, data review, and ownership of department projects. You will develop long-term strategies, manage a team of people leaders and professionals, and collaborate with QA, manufacturing, and maintenance to meet business objectives while ensuring compliance with cGMP and regulatory expectations.