We are searching for a Kilo Lab Supervisor to join an emerging pharmaceutical company in suburban Cleveland.
Requirements for the Kilo Lab Supervisor:
- BS in Organic Chemistry or relevant field. Advanced degrees preferred.
- Previous industry experience in GMP laboratory and Kilo Laboratory a must.
- Working knowledge of ICH Q7 cGMP requirements and guidelines.
- Able to work effectively with minimal guidance and supervision.
- Excellent knowledge of chemistry and analytical techniques.
Responsibilities for the Kilo Lab Supervisor:
- Manage, supervise and oversee kilo lab technicians, providing training on equipment and processes when necessary.
- Perform production scale-up activities in support of R&D.
- Operate as the lead manufacturing production chemist and execute cGMP production in preclinical – commercial APIs scheduled within cGMP kilo lab.
- Responsible for authoring process batch records (PBR), cleaning records (CBR) and other necessary documentation as according to regulatory guidelines.
- Coordinate cross functional activities between support groups such as QC and QA to achieve goals.
- Contribute to the development of the design and specification of process equipment, process definition and facility modifications necessary to meet clinical and scale-up requirements.
- Ensure that facility meets specific chemistry requirements based on raw material hazards, facility design, technologies required, equipment utilization, etc.
- Lead scale-up/preparation of complex multi-step organic synthesis process for specialty and pharmaceutical chemicals.
- Support technology transfer between labs.
: Please apply using the form or send your resume to Debbie Winkelbauer