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.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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.
Responsibilities:
- 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
Additional Preferences:
- Experience working with radiopharmaceuticals will be considered an asset but is not a requirement
- Manage multiple projects, set priorities, and work in a fast-paced environment
- Excellent oral and written communication skills
- Demonstrated ability to function well in a collaborative team environment
- Excellent organizational and interpersonal skills
- Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a lab/office environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is both in a Laboratory and Office setting.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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