Research Scientist
Eli Lilly 380 reviews - Indianapolis, IN

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This position is responsible for the development and utilization of methods to analyze in-process, active pharmaceutical ingredients and drug products for microbial contamination, and to provide technical input into microbial control strategies for these products.
  • Support bioproduct and pharmaceutical product development formulation teams through screening new formulation candidates for antimicrobial activity.
  • Consult with development teams and other internal customers on the microbial contamination control issues and strategies related to pharmaceutical development.
  • Conduct or coordinate the development and verification/ qualification/validation/transfer of microbiological analysis methods to support of API and drug product.
  • Responsible for all aspects of laboratory operations, such as sample receipt, data generation, verification, and interpretation, aberrant data and out-of-specification investigations, instrument qualification, operation, and troubleshooting, and all supporting documentation for such activities.
  • Responsible for the appropriate use of informatics interfaces within the laboratory.
  • Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
  • Keep abreast of relevant new technologies/ capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
  • Authorship of technical reports and regulatory documents.
  • Supervision, coaching, training, and administration of performance management to assigned personnel.
  • Ensure work is aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements.

Basic Qualifications
  • Bachelor's degree in microbiology, biochemistry, molecular/cell biology, or related field; alternatively, skills commensurate with a Bachelor's degree microbiologist.
  • Minimum of 5 years working in a microbiology lab experience. Capable of designing experiments, generating data, interpreting results, and documenting the work, independently. Documenting the work
  • Microbiology experience with knowledge of one or more of the following, as appropriate: microbial isolation and characterization, aseptic techniques, molecular biology, and bioanalytical sciences.
  • Minimum of 5 years of cGMP/GLP compliance requirements.

Additional Skills/Preferences
  • Master's degree in microbiology, biochemistry, molecular/cell biology, or related field; alternatively, skills commensurate with a Master's degree microbiologist.
  • Effective oral and written communication skills, self-management, task planning and organization.
  • Must be able to work productively in an interdisciplinary team environment.
  • Microbiology or related laboratory experiences within the last 5 years.

Additional Information


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About this company
380 reviews
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...