Lilly Scientist–PAT–TS/MS–IAPI in Indianapolis, Indiana
The Scientist–PAT–TS/MS –IAPI participates in equipment evaluations and qualifications, method development/validations and improvements, computer system validation as well as author/execute well-defined protocols and procedures. The scientist completes second person verification of others results and shares technical information and best practice within the group.
Understand the scientific principles for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
Be capable of preparing relevant technical documents, such as: technical reports, change controls, deviations/observations, validation protocols, summary reports, procedures, data integrity assessments, etc.
Assist in improvement of quality systems by creating or revising worksheets and other PAT documentation systems.
Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformances to procedure, standards and protocols and/or real-time recognition of aberrant data and results.
Review SOPs for executable as written.
Comply with and implement safety standards.
Train and mentor others. Develop training materials.
Performs second person verification of others results/reports
May perform holistic review of process analytical data (i.e. Patrol, PI)
May perform and contribute to Periodic Quality Evaluation (PQE), as required.
Collaborate with frontline representative(s), Quality Control, TS/MS lab, and process team to meet PAT requirements.
Troubleshoot equipment and methods as required.
Maintain and improve quality systems.
Participate in self-assessment and regulatory agency inspections.
High quality skills to include: Teamwork and interpersonal communication skills, technical knowledge, sound decision making, multi-tasking, ability to influence groups, written and oral communication skills, computer skills, statistical analysis, and problem solving
Demonstrated strong problem solving and analytical thinking skills
Strong computer skills (DeltaV, JMP, Excel, PI)
Relevant industrial experience in any of the following disciplines such as Protein Manufacturing, Development, and Quality Control
Computer Systems Validation Experience
Knowledge or experience with Thermo On-Line HPLC or Chromeleon chromatography software.
Must complete applicable learning plan requirements.
Day Shift. May require working off hours to support urgent business needs.
Lilly is an EEO/Affirmative Action Employer and 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.
Scientist–Mfg Sciences- Technical Services
Bachelor’s degree in relevant discipline such as Engineering, Analytical Chemistry, or Biology
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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 39,000 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.
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