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.

Description of Role/Position :

The Lead Specialist - Analytical (Shift Lead) is a senior member of the Quality Control Laboratory who provides shift‑level operational leadership, technical guidance, compliance with cGMP standards, and quality oversight within the QC laboratory. This role ensures compliant execution of analytical testing, effective issue resolution, and consistent performance across the shift.

The Lead Specialist - Analytical (Shift Lead) may also perform various analytical tests/assays to determine the identity, quality and purity of samples in accordance with established quality control procedures and methods. The Lead Specialist - Analytical (Shift Lead) will support the analytical testing required during new product introduction, including method transfer and validation. Will lead data verification, audit trail and staff training.

Key Responsibilities :

Provide day‑to‑day operational oversight of laboratory activities during the assigned shift, ensuring testing activities are appropriately prioritized, resourced, and executed in line with the agreed schedule.
Coordinate task allocation, monitor progress against plan, and address short‑term capacity or workflow constraints, escalating risks to timelines, quality, or compliance as required.
Provides operational coordination without direct people management or performance accountability.
Perform comprehensive data review and prepare certification documentation in accordance with cGMP, GDP, and Data Integrity requirements.
Act as a shift-level quality champion, driving inspection readiness and consistent adherence to laboratory procedures.
Serve as the frontline point of contact during the shift for operational and technical escalations.
Provide initial frontline technical support to the QC laboratory analysts regarding test methods execution troubleshooting, and prioritization. Responsible for escalating barriers to the relevant scientist and management as appropriate.
Provide guidance to QC Analysts on test execution, scheduling Adherence,
Proactively identify risks to compliance, timelines, or data integrity and escalate appropriately to Scientists, QC leadership, or Management.
Coordinate with Process Team and Quality to remove operational barriers and maintain laboratory flow.
Lead training of QC Analysts, ensuring consistent application of methods and procedures. 
Contribute to training effectiveness by identifying gaps, supporting retraining activities, and escalating training needs to management.
Overall ownership of the lab preparation and execution elements of method transfer
Engage directly with personnel to address atypical results, equipment malfunctions, or other operational problems. Anticipate potential problems, take proactive action, and seek assistance/escalate, as needed.
Perform routine analyses on a variety of sample types using established analytical methods. Conduct testing in accordance with established laboratory procedures and GMP requirements.
Maintain compliance with HSE, cGMP, and GDP requirements.
Drive data integrity and inspection readiness.
Support continuous improvement and optimization of lab processes.
Reporting results into a computer storage system (LIMS), as well as performing testing using automated systems.
Involved in the qualification of analytical instruments and in their routine maintenance. 
Development, validation and verification of new methodologies, as part of new product introductions or process improvement activities.
Involved in deviation investigations and will record any errors encountered, as per procedures and training.
Following all relevant Environmental, Health and Safety procedures and involved in incident investigations as required.
Responsible for adhering to, and improving, where appropriate, safety procedures to protect their other personnel and company property.
Lead area or cross-functional continuous improvement projects e.g. Six Sigma or other appropriate methodology.

Educational Qualifications/ Experience Required :

BSc in Analytical Sciences (Chemistry, Biochemistry, Microbiology or equivalent) with a minimum of 5 years pharmaceutical experience.
Comprehensive knowledge of quality control operations with an emphasis on analytical techniques such as quantitative PCR, chromatography, capillary electrophoresis, spectroscopy, and Laboratory Systems.
Demonstrated understanding of Data Integrity and its application in a Digital Laboratory.

Additional Skills/ Preferences :

Demonstrated problem solving and leadership skills.
Great Communication skills.
Excellent attention to detail in all aspects of the work.
Knowledgeable of general scientific methods and capable of learning and executing new techniques and instrumentation after appropriate training.
Displaying a high level of integrity in the performance of their work. 
Relating well to other people with whom they come in contact, both within and outside of the laboratory area.
Has ownership of a process or procedure.

Additional Requirements/ Information :

Must be able to travel for familiarization and training as required.
This role is required to work on a shift basis.

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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Lead Specialist - Analytical (Shift Lead)

Job Description