Manager QC Chemistry Laboratory

at  Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

POSITION SUMMARY:

The Manager of QC Chemistry Laboratory will have functional responsibility for QC testing of radiopharmaceuticals in accordance with GMP guidelines and relevant regulatory requirements. This on-site position will have the responsibility to maintain the day-to-day operations of the QC Laboratory including direct reports.

Basic Requirements:

• Bachelor or Master of Science degree in Chemistry and/or related sciences
• Minimum of 5 years’ of previous analytical pharmaceutical GMP laboratory management experience
• An excellent understanding and knowledge of chemistry and analytical instrumentation technologies
• Experience with HPLC analytical testing and methodologies required
• Experience leading project team(s) and mentoring and coaching others to achieve result

• Managing and leading the analytical laboratory team members to effectively execute day-to-day release requirements.
• Provide scientific and technical leadership to ensure timely and effective investigation of out-of-specification and out-of-trend test data.
• Ensure project deliverables and timelines are met and manage risk making appropriate technical decisions to keep projects on track and providing timely updates to senior management.
• Maintain a GMP compliant analytical laboratory and safe working environment.
• Accountable for preparing and maintaining accurate and complete QC analytical data in accordance with Good Documentation Practices for GMP manufacturing.
• Provide training to laboratory personnel in analytical procedure and instrumentation.
• Generate and tracking internal QC related quality KPIs
• Set goals, review performance and assess training needs for the department as well as QC staff.
• Review technical data and documents as required.
• Perform other duties as required.

Basic Requirements:

• Bachelor or Master of Science degree in Chemistry and/or related sciences
• Minimum of 5 years’ of previous analytical pharmaceutical GMP laboratory management experience
• An excellent understanding and knowledge of chemistry and analytical instrumentation technologies
• Experience with HPLC analytical testing and methodologies required
• Experience leading project team(s) and mentoring and coaching others to achieve results