Cayman Chemical Company is a biomedical research company based in Ann Arbor, Michigan. Cayman helps make research possible by supplying scientists worldwide with biochemical tools used to understand cancer, neurochemistry, oxidative injury, endocrinology, atherosclerosis, and other human health challenges. We specialize in assay kits for the measurement of hormones and bio-markers. In addition, Cayman offers a broad range of specialty biochemicals used as research reagents and qualified standards. Cayman performs generic drug development and production in both Ann Arbor, Michigan and Neratovice, Czech Republic.
We are currently seeking candidates for the position of Vice President of GMP Global Operations. The successful candidate will be responsible for:
•Oversee global cGMP operations and chemical manufacturing facilities in Ann Arbor, Michigan and Neratovice, Czech Republic. These facilities are multi-product facilities capable of the simultaneous manufacturing of API’s and are about ready to embark on a project to expand capacity, including facility validation. Between both locations there are approximately 120 staff including support functions.
•Full accountability for business development, manufacturing, validation, and quality functions associated with the delivery of API products. Responsible for the quality oversight for drug-product manufacture under current Good Manufacturing Practice (cGMP) and other applicable regulations.
◦Business Development functions include building and fostering both current and new relationships with our customers
◦Manufacturing functions include API manufacturing, plant operations, raw material procurement, and technology/process transfer.
◦Validation activities include validation maintenance and life cycle management for plant equipment and laboratory instrumentation. Engineering & validation functions include project and process engineering, instrumentation, control systems, and preventive maintenance systems.
◦Quality control functions include raw material, in process, product release and stability testing, analytical tech transfer to world markets, compliance systems including IT systems, and document control functions.
•Oversee the Quality Assurance (QA) and Quality Control (QC) functions.
◦The head of Quality: Manages regulatory registrations and interactions with regulatory agencies and customer compliance groups during inspections and audits. Conducts internal audits, works with external auditors, evaluates suppliers and new projects, and oversees technology transfer and facility validations. Resolves regulatory concerns resulting from submission documentation.
•Oversee chemical process scale up, reaction equipment design and process safety testing.
•Responsible for all plant production, engineering, maintenance, capital projects, and associated financials in support of an 80,000 ft2 biopharmaceutical GMP clinical trial production facility.
•Develop and manage Cayman's supply chain and in house cGMP operations for API product portfolio.
•Supervise daily operations at API locations, develop operating plans and project milestones and ensure the successful achievement of project goals.
•Ensure personnel and resources are effectively utilized to maximize efficiency and monitors project activities to facilitate the achievement of all key project objectives.