Eli Lilly and Company
Indianapolis, IN, United States
Quality, Chemistry, Sciences
Jul 21, 2021
Nov 03, 2021
Sr Chemist - Quality Control IAPI
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 35,000 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.
At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Position Brand Description:
The Chemist – QC - IAPI (Purchased Materials) performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The chemist completes second person verification, with an emphasis on data integrity, of other analysts results. The chemist also participates in laboratory root cause investigations, equipment evaluations, qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The chemist shares technical information and best practice within plant sites or group.
The position is responsible for technical mentoring of laboratory staff and sharing technical information and best practices within the work group and across plant sites. The Chemist – QC – IAPI (Purchased Materials) participates and influences the technical agenda of the plant or corporation.
Perform testing of incoming purchased materials in according with regulatory commitments
Technical understanding of compendia requirements, use of traceable standards and maintaining certificates of compliance
Understand the scientific principles required for manufacturing and testing of intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess analytical vs. process variability and capability.
Provide technical support to non-routine (e.g., deviation) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validation Protocols, Tickets, Procedures, PFDs, Periodic Quality Evaluations, etc.
Support production floor operations through change proposals, investigations, and deviation root cause analysis.
Maintain and improve quality systems including method remediation.
Participate in self-assessments and regulatory agency inspections.
Ensure internal and external quality and supply commitments are met.
Manage the review and retention of cGMP documents.
Participate in Lean and 5s.
Bachelor degree in a scientific field or equivalent experience; 5 years of demonstrated relevant experience in a GMP laboratory
Previous experience in a high throughput raw material testing lab (e.g., melting point, wet chemical tests, titrations, heavy metals, visual inspection.)
Experience with validated computer systems (e.g., Darwin, SmartLab and/or Empower)
Experience and knowledge of cGMP requirements in API manufacturing
Previous experience with various compendia and testing methods
Demonstrated strong problem solving and analytical thinking skills
Understanding of statistical tools and analysis
Experience with electronic notebooks
Excellent interpersonal skills and networking skills
Experience in QC, Manufacturing, or Tech Services especially in large molecule (BLA) manufacturing
Demonstrated strong written and verbal communications skills
Strong attention to detail
Ability to organize and prioritize multiple tasks
Must complete applicable learning plan
Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
May be required to provide 24 hour on call coverage, as necessary
Overtime or weekend work, as necessary
Note: Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.
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 ( Lilly
Compliance@lists.lilly.com ) 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 is an EEO/Affirmative Action Employer and 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
Eli Lilly and Company
Website : http://www.lilly.com