Chemist - QC-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 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.

Organization 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.

Key Objectives /Deliverables: 
• 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. 
• Must follow data integrity practices and procedures. (ALCOA + principles ).

Basic Requirements: 
• Bachelor’s Degree in a science related field.

Additional Preferences: 
• Demonstrated strong problem solving and analytical thinking skills. 
• Understanding of statistical tools and analysis. 
• Excellent interpersonal skills and networking skills. 
• Experience in QA, QC, Manufacturing, Tech Services, or Regulatory Affairs. 
• Demonstrated strong written and verbal communications skills. 
• Strong attention to detail. 
• Ability to organize and prioritize multiple tasks. 
• Experience and knowledge of cGMP requirements. 

• Familiarity with wet chemistry techniques, HPLC, GC, FTIR, UV/Vis, Titrations

Other Information: 
• Must complete applicable Learning Plan. 
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. 
• Overtime or on-call hours may be required in order to meet business needs. 
• Unless approved by leadership, Chemist-QC-IAPI is considered an on-site position. 
• Must adhere to policies and guidelines outlined in the employee handbook and Red Book.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chine