Associate Consultant - Biologist- Quality Control
Eli Lilly and Company
6 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Maintain a safe work environment and support HSE Corporate and Site Goals.
- Champion Site Impact Assessment for Compendial and GQS updates.
- Serve as local data steward / laboratory key site contact for new molecule implementation.
- Lead/supervise method transfers, validations, or verifications for new molecules.
- Author technical documents and change controls to support commercialization, new methods, and new reference standards.
- Participate in APLOT and commercialization meetings; complete steps for global changes as applicable.
- Support global analytical stewards by gathering information on new methods; work with GQL and PR&D.
- Support audit activities.
- Act as local technical SME for micro methods; provide method management for respective IPM laboratories.
- Perform technical review/interpretation/release of data (e.g., CoT issuance, stability results, reference standard characterization).
- Perform technical training; coach analysts in real time and mentor through formal process/program.
- Review and approve change controls and deviations.
- Review/interpret data and document results in summary reports per GMP and local guidelines.
- Develop investigational testing protocols; perform testing as required.
- Perform method validation/remediation; research and recommend new technologies.
Basic Requirements:
- BSc or MSc in chemistry, biology, engineering, or equivalent scientific/technical degree.
- 3+ years’ experience in a GMP QC laboratory and/or pharmaceutical industry.
- Demonstrated ability to lead projects.
- Experience supporting regulatory inspections.
- Strong influencing, interpersonal, and teamwork skills.
- Strong technical writing and communication skills.
- Strong self-management and organizational skills.
Additional Skills/Preferences:
- Proficiency in complex laboratory analysis (chromatographic, spectroscopic, and/or microbiological assays).
- Ability to work in a lab environment with appropriate PPE.
- Deep understanding of compliance requirements and regulatory expectations.
Additional Information:
- Work 8-hour days, Monday–Friday; may need to cover weekends/holidays/company shutdowns as needed.
- Minimal travel required.
- Work in various areas of the Parenteral Plant; consider allergen exposure and mobility requirements.
- Tasks may require repetitive motion (e.g., keyboarding).
Benefits:
- Full-time eligible employees may participate in a company bonus program (company/individual performance-dependent).
- Comprehensive benefits: 401(k) eligibility, pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., EAP, fitness, clubs/activities).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Maintain a safe work environment and support HSE Corporate and Site Goals.
- Champion Site Impact Assessment for Compendial and GQS updates.
- Serve as local data steward / laboratory key site contact for new molecule implementation.
- Lead/supervise method transfers, validations, or verifications for new molecules.
- Author technical documents and change controls to support commercialization, new methods, and new reference standards.
- Participate in APLOT and commercialization meetings; complete steps for global changes as applicable.
- Support global analytical stewards by gathering information on new methods; work with GQL and PR&D.
- Support audit activities.
- Act as local technical SME for micro methods; provide method management for respective IPM laboratories.
- Perform technical review/interpretation/release of data (e.g., CoT issuance, stability results, reference standard characterization).
- Perform technical training; coach analysts in real time and mentor through formal process/program.
- Review and approve change controls and deviations.
- Review/interpret data and document results in summary reports per GMP and local guidelines.
- Develop investigational testing protocols; perform testing as required.
- Perform method validation/remediation; research and recommend new technologies.
Basic Requirements:
- BSc or MSc in chemistry, biology, engineering, or equivalent scientific/technical degree.
- 3+ years’ experience in a GMP QC laboratory and/or pharmaceutical industry.
- Demonstrated ability to lead projects.
- Experience supporting regulatory inspections.
- Strong influencing, interpersonal, and teamwork skills.
- Strong technical writing and communication skills.
- Strong self-management and organizational skills.
Additional Skills/Preferences:
- Proficiency in complex laboratory analysis (chromatographic, spectroscopic, and/or microbiological assays).
- Ability to work in a lab environment with appropriate PPE.
- Deep understanding of compliance requirements and regulatory expectations.
Additional Information:
- Work 8-hour days, Monday–Friday; may need to cover weekends/holidays/company shutdowns as needed.
- Minimal travel required.
- Work in various areas of the Parenteral Plant; consider allergen exposure and mobility requirements.
- Tasks may require repetitive motion (e.g., keyboarding).
Benefits:
- Full-time eligible employees may participate in a company bonus program (company/individual performance-dependent).
- Comprehensive benefits: 401(k) eligibility, pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., EAP, fitness, clubs/activities).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation