Sr Manager, QC Microbiology

This growing biotech company dedicated to developing innovative treatments for advanced cancers and infectious diseases. Their mission is to improve patient outcomes through cutting-edge research and development.

They are in search of a Senior Manager, Quality Control (Microbiology) who will oversee the microbiology quality control activities to ensure the safety and efficacy of our products. This position will manage the microbiology laboratory operations, ensuring compliance with regulatory standards and company policies.

Position Summary

The Senior Manager, Quality Control Microbiology role provides QC-Micro leadership for the company's early phase (phase I/II) clinical and commercial manufacturing operations, Contract Manufacturing Organizations, and Contract Testing Laboratories. This role is responsible for overseeing all GMP QC Microbiology activities supporting clinical and commercial manufacturing operations which includes maintenance of QC Micro sections for global regulatory applications, as well as regulatory support functions for inspections or information requests. Specific areas of responsibility include, but are not limited to, design and oversee: the environmental monitoring program (EM), the personnel monitoring program (PM), all in-process and release testing (microbiology), all raw materials testing (microbiology), method establishment of microbiological assays, aseptic processing training program, utilities testing program (microbiology), facilities qualification (EMPQ), and cleaning validations. This position interacts cross-functionally with the Manufacturing, Facilities, Engineering, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.

Professional Experience

Bachelor's degree in microbiology or biology, with a minimum of10+ years of microbiology/sterility control required; or

Master's degree in microbiology or biology, with a minimum of 8+ years of microbiology/sterility control required.

7+ years of management experience required

Experience qualifying GMP manufacturing facilities (EMPQ, utilities qualification and validation) required

Experience managing Contract Testing Laboratories required

Experience hiring, training, and leading cross-functional teams required

Experience in aseptic manufacturing operations within a GMP regulated Biologics or Pharmaceutical environment required

Experience with a start-up pharmaceutical company preferred.

Experience with the simultaneous management of multiple products through early phase clinical trials preferred

If you believe you'd make a good fit for this role, please apply in directly.