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.
We are looking for a Sr. Principal Associate – Microbiology to join our manufacturing site. In this role, you will serve as a technical leader in microbiology and quality control laboratory operations, ensuring compliance with current Good Manufacturing Practices (GMP) and global regulatory standards (FDA, EMA, Pharmacopoeia, ISO), and will report directly to the Director – QC Laboratory.
Key Responsibilities
- Manage and maintain quality systems within the QC microbiology laboratory, providing technical leadership across method validation, critical equipment qualification (isolators, autoclaves, endotoxin readers), and analytical problem-solving.
- Act as Lead Investigator for critical microbiology-related investigations, including sterility failures, bioburden and endotoxin out-of-specification results, bioassay deviations, and container closure integrity issues.
- Evaluate and implement Global Quality Standards (GQS), Common Quality Practices (CQP), and Pharmacopoeia updates, serving as the key local contact for global coordination.
- be a Subject Matter Expert and primary point of reference during internal and external inspections, always ensuring inspection readiness.
- Oversee contract laboratory relationships for microbiological testing, managing technical oversight and issue resolution.
- Coordinate laboratory projects and new product launches related to microbiology and sterility assurance, support the regulatory affairs team with QC-specific technical expertise, and actively participate in international networks and forums (APLOTs, GPLOTs, GQL, lab networks).
- Contribute to analyst development, review and approve relevant procedures and change controls, and serve as a back-up for analytical result release.
Requirements:
- Master’s degree in biology, microbiology, Biotechnology, Pharmaceutical Chemistry and Technology (CTF), or Pharmacy. PhD preferred.
- At least 8 years of experience in the pharmaceutical industry with a strong background in pharmaceutical microbiology and GMP quality control laboratory operations.
- Deep knowledge of FDA and EMA guidelines, Pharmacopoeia requirements, and ISO standards.
- Proven ability to lead investigations, manage cross-functional projects, and influence quality standards both locally and globally.
- Experience interfacing with global quality teams and external professional associations.
This position requires working on-site, and includes 4 days of remote work per month.
What we offer:
Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:
- Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.
- Relocation Package: You will be eligible for a relocation package based on your location.
- Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.
- Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.
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 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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