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 a GMP Quality Assurance Manager with the key duties and skills listed
Develops and maintains a culture promoting quality and continuous improvement.
Develops and maintains a strategy to meet the requirements of health authorities, including the FDA.
Develops policies and procedures in compliance with CGMP and regulatory requirements.
Represent QA on API project teams, take responsibility for the quality aspects of the project including
communication to the project manager and team. Manage the quality aspects of client-driven projects including
the execution of quality and technical agreements.
Promote and maintain a high standard of customer care, participating in client visits as required.
Participate in the management, control, and assessment of vendors, suppliers, and contractors.
Conducts internal and external audits to verify compliance with CGMP expectations.
Host client and health authority audits.
Identify, develop, and deliver training on quality systems and procedures to colleagues throughout the GMP
Performs full reviews of executed documents:
• including manufacturing batch records, packaging batch records, stability testing, and validation
protocols, inclusive of all supporting test plans and analytical data
• provides training to others for this task
• approves execution of these documents
Responsible for the release and disposition of GMP APIs, starting material, and intermediates.
Lead and participate in quality investigations, risk assessments, and development and execution of corrective
action / preventive action plans.
Drives GMP continuous improvement initiatives.
Review and analyze data for regulatory documentation including Annual Product Reviews and Drug Master Files.
Maintains compliance with all company policies, plans and procedures, including but not limited to safety, security
Skills & Requirements:
Bachelor’s degree in life sciences with a strong preference for a degree in Chemistry or Engineering.
Preferred to have at least ten years relevant experience in a GMP or highly regulated environment, including at
least five in lab experience and five in quality systems.
Must have the ability to:
• create and maintain a positive team-oriented attitude
• manage and prioritize competing objectives
• lead a team of diverse individuals
• make independent decisions
• prepare effective technical and training documents
• communicate clearly and effectively
• identify and resolve problems
Attention to detail and good organizational skills are a must.
Extensive experience with GMP Quality Management and a comprehensive understanding of CGMP regulations
including those issued by the FDA.
Proficient computer skills with documentation related databases, Microsoft Office and Adobe Acrobat.
About Cayman Chemical
Headquartered in Ann Arbor, Michigan, Cayman Chemical Company supplies scientists worldwide with the resources necessary for advancing human and animal health. We manufacture high quality biochemicals, assay kits, antibodies, and recombinant proteins and offer contract services for custom chemical synthesis/analysis, assay development/screening, and drug discovery.
Our mission is to help make research possible. That starts by employing a talented and highly qualified group of experts to develop the tools to support research scientists across academic, biotechnology, and pharmaceutical institutions. Our scientists are experts in the synthesis, purification, and characterization of a wide-range of biochemicals. We are highly skilled in all aspects of assay and antibody development and are fully accomplished at protein expression, crystallization, and structure determination.