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
If you believe you'd make a good fit for this role, please apply in directly.
...Teacher Vision Pharos Academy Charter School is looking for a teacher who is an uber kid person. The ideal candidate absolutely loves to teach, train,... ...certification are welcomed to apply)# Experience working with high school-aged children in an academic or youth...
...Overview: B&H is looking for Photography Content Writers to craft product descriptions, research products, and update the B&H website with... ...vs zoom debate A fondness for digital but a preference for film Level 1/Junior Content Writer Typically responsible for...
...We are seeking a dedicated High School Teacher to join our team at RMA. The ideal candidate will help students learn subject matter and skills that will contribute to their development as mature, knowledgeable, and responsible individuals. This role requires a passion...
Boss JCB is a fast-growing JCB dealer with a strong commitment to be the best service department in the area. We are looking for Technicians that want to grow their careers with a company that will support them and be proud of. Seeking a Mobile Construction Equipment ...
...Job Title : Executive Administrative Assistant (Bilingual in Spanish Preferred) Date: 05/2025 Reports to: CFO Compensation: Salary with annual bonus potential SWE Homes is a Houston-based real estate and investment company located near the Galleria area....