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.
Senior Data Scientists on our team partner with product managers, SMEs and our clients to form a cross-functional team driving optimization of precious healthcare resources.We are looking for strong, enthusiastic data scientists to join the team focusing on value creating...
...ManTech seeks a motivated, experienced career and client-oriented Data Engineer to join our team onsite in Alexandria, VA. In... ...stakeholders to understand data requirements to facilitate analytics and machine learning uses. Architect data pipelines and data...
...conducir vlida con un historial de manejo seguro; (3) acceso a un vehculo asegurado que se puede utilizar para la entrega. Puede cumplir con estos requisitos? Informacin adicional All your information will be kept confidential according to EEO guidelines....
Coach is seeking a Temporary Support Associate in Pleasant Prairie, WI. This role involves supporting the sales team, maintaining store standards, and providing excellent customer service. Ideal candidates will have prior retail experience and strong organizational skills...
...Insight Global is looking for a Security Escort with an active Top Secret SCI with CI/FS Polygraph to work onsite at Buckley AFB... ...individuals/visitors that do not have the appropriate security clearances and or access authorization into designated buildings and...