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.
- 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.
- 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.
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER
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