Chemist Kilo Lab Sup

Relocation eligible, competitive salary, great benefits right here in the "medical mecca" of the Midwest with Best in the Nation health systems: Cleveland Clinic and University Hospitals. We offer: 2 medical plans, dental, vision, company-paid + supplemental life & income replacement benefits, 401k with company match-JOIN US!!

Essential Responsibilities:• Supervise and develop kilo lab technicians
• Perform production scale-up activities in support of research and development within kilo lab
• Execute cGMP production as the lead manufacturing production chemist of preclinical - commercial APIs scheduled within cGMP kilo lab
• Support technology transfer from Process Chemistry to Kilo Lab and Kilo Lab to Pilot Plant
• Manage all projects to be conducted within the cGMP kilo labs
• Author process batch records (PBR) and cleaning records (CBR)
• Assess capability of facility to execute specific chemistries based on raw material hazards, facility design, technologies required, equipment utilization, and manpower needs
• Train and coach kilo lab technicians in the operations of new equipment and processes
• Collaborate with other team members of Process Development of the company on design and specification of process equipment, process definition and facility modifications necessary to meet clinical and scale-up requirements
• Prepare technical reports and standard operating procedures
• Communicate project status and issues encountered
• Ensure accurate documentation and work in compliance with standard operating and safety procedures
• Adhere to general and site safety and ICH Q7 cGMP requirements and guidelines
• Perform other duties as assigned
• Project Leader for first-time scale-up/preparation of complex multi-step organic synthesis process for specialty and pharmaceutical chemicals.
• Coordinate activities of operations and support groups (Process Chemistry, Quality Control, Analytical Chemistry, Quality Assurance, Facilities Management) to achieve project goals
• Identify areas of continuous improvement

Core Skills:• Works effectively in multi-disciplinary team environment
• Applies proficiency in chemistry gained by education and experience
• Effectively interacts across internal divisions and with clients
• Effective time management and multi-tasking
• Technical, operational and fiscal responsibility for assigned projects
• Exhibits good judgment and makes sound decisions with minimal guidance
• Good troubleshooting and problem-solving skills

Education and/or Experience:• BS / MS degree in organic chemistry or equivalent experience
• Good working knowledge of analytical techniques
• Experience in a CRO or CMO environment is desirable
• Experience with kilo lab-scale processing is preferred
• Familiarity with a cGMP regulatory environment is a plus

We offer a competitive salary along with a comprehensive benefit plan and a great workplace with really smart people, so join us!

Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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