Sr. Manager, QC Microbiology

The role

The Sr. Manager, QC Microbiology manages the operation and workflow of quality control microbiology laboratories to support cell therapy manufacturing. This role involves managing staff, reviewing laboratory test data, and implementing microbiology procedures and methods.

What you will do

• Manage the operation and workflow of quality control microbiology laboratories.
• Hire, develop, and perform performance management of staff.
• Review and approve laboratory test data.
• Develop and implement microbiology procedures and methods.
• Support laboratory investigations and manage QC microbiology department projects.
• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
• Manage and support Investigation of laboratory non-conformances.
• Maintain, calibrate and qualify laboratory instruments and equipment.
• Perform test method verification, qualification, validation and/or transfer activities.
• Manage departmental budget and resources and prepare staffing plans.

Required qualifications

• Bachelor’s Degree in Science, Biology or equivalent technical discipline
• 12 to 14 years relevant work experience
• 3-5 years of leadership experience
• Experience working with Quality systems
• Extensive knowledge of chemical, biochemical and microbiological concepts
• Ability to apply basic and advanced mathematical concepts including statistics
• Knowledge of cGMP regulations and FDA/EU guidance
• Comfortable with speaking and interacting with inspectors
• Good written and verbal communication skills
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing
• Proven people management and leadership experience
• Ability to summarize and present results

Nice to have

• Experience working in an aseptic manufacturing facility
• Experience in microbiology quality control laboratory, quality assurance, or cell therapy
• In-depth knowledge and experience in biopharmaceutical analysis method verification
• Experience in microbiological test methods and EM

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight weeks of paid parental leave after three months of employment
• Paid time off including vacation, personal, sick, floating holidays, and eleven company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Commuter benefits
• Family planning and care resources
• Well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy through a portfolio of innovative technologies.