Principal Biologist

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.

Position Description:

The Principal Microbiologist performs accurate and timely testing of routine and non-routine lab samples in accordance with appropriate GMP and safety guidelines. The microbiologist is responsible for performing data review activities within the department, as required. The microbiologist participates in and documents laboratory investigations as well as deviation investigations. The microbiologist will be required to provide support or assistance with equipment qualifications, method transfers/verifications, continuous improvement initiatives as well as document authorship activities. The microbiologist shares technical information and best practices within department and with cross-functional teams. The microbiologist provides training support for the team (sterility, bioburden, endotoxin, TOC, Conductivity, growth promotion, suitability testing, etc.).

Key Objectives/Deliverables:

• Accurately and safely perform microbiological and chemical testing of water, clean steam, environmental monitoring, and compressed gases per established testing procedures and protocols.

• Accurately and safely perform microbiological testing of product.

• Accurately record data in reports or in accordance with laboratory procedures, standards, and GMP requirements.

• Recognizes deviations from procedures, methods, etc. and initiates an investigation as required.

• Perform technical review of analytical data, as required.

• Adhere to all Environmental, Health, and Safety standards.

• Identify and communicate opportunities for improvement initiatives in daily work activities.

• Troubleshoot equipment and methods, as required.

• Support lean lab and 5S initiatives.

• Understand the scientific principles (compendial requirements and industry standards) required for testing of drug substances and drug product, including the interaction of the chemistry and lab equipment.

• Provide technical support for investigations.

• Maintain inventory of all supplies and consumables for the laboratory.

Requirements:

• Bachelor (4-year college) degree in a life or applied science (Biology or Microbiology preferred)

• At least five years of experience working within a GMP microbiology laboratory.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Preferred attributes but not required:

• Experience with electronic laboratory management systems (E.g., LIMS, MODA)

• Experience with Quality Management systems.

• Laboratory experience with various microbiological techniques and instrumentation (E.g., Aseptic Techniques, Conductivity, TOC, Sterility, Endotoxin, Bioburden, Microbial Enumeration, Microbial Identification, Particulate Matter).

• Experience in operational excellence, such as lean and 5S initiatives.

Additional Information:

• 8-hour days – Monday through Friday, with occasional weekend support of a 24/7 manufacturing operation.

• Minimal travel required.

• Ability to work in various areas within the site.  Some allergens are present in the parenteral plant.

• Tasks may require repetitive motion (e.g., keyboarding).

• Employees may be requested to complete a vision assessment including checking for colorblindness

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 th