Principal Chemist

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.

Responsibilities:

This position offers technical oversight of batch release activities. The Principal Associate, QC Principal Scientist will be primarily responsible for performing technical review of batch release and stability data. This role will participate and influence the generation of certificates of analysis and certificates of testing at the LKC site. The role may require testing of routine lab samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements.

Key Objectives/Deliverables:

• Perform final batch disposition of intermediates, semi-finished and/or finished drug product batches to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.

• Effectively review/approve GMP documents to ensure quality attributes are met (i.e. Non-conformances, procedures, protocols and specifications)

• Participate in the transfer of analytical methods for marketed products, including authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations

• Assist with development of investigational testing protocols and perform testing as required. (Senior and Principal Chemist roles)

• Author SOPs and training documentation.

• Execute inspection readiness activities in the QC laboratories.

• Interact effectively with auditors and business partners.

• Train and mentor lab personnel.

• Support Lean Lab initiatives and efficient lab operations.

• Comply with and assist with implementing safety standards

Basic Qualifications:

• Bachelor's degree in a science or engineering discipline (Chemistry, Biology, Chemical Engineering, Biomedical Engineering, etc.) required . Master's degree preferred.

• 5 years of pharmaceutical industry experience required

• GMP Laboratory experience including familiarity with analytical testing, stability program execution and good documentation practices.

• Previous experience with enterprise chromatography systems and stand lone COTS testing instruments.

• Previous experience with LC instruments required.

• Experience with statistics and data analysis software, especially data visualization.

Additional Skills/ Preferences:

• Experience with Empower and Darwin LIMS

• Strong technical aptitude

• Understanding of compliance requirements and regulatory expectations.

• Working effectively with a cross functional group

• Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.

• Ability to focus on continuous improvement.

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 ( ) 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, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.