Scientist

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 35,000 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.

Provides technical support for Product Protection Control activities supporting Indianapolis API manufacturing.

Responsibilities:

• Prepare, review and approve (as required) relevant technical documents, such as: Change Controls, Events, Procedures, Protocols pertaining to production equipment cleaning and other product protection control areas of focus.
• Collaborate with Frontline TS/MS to ensure appropriate execution of all Product Protection Control deliverables, specifically with regards to cleaning verification, validation, and changeover cleaning.
• Provide assistance with process monitoring and data review, when necessary
• Conduct and Author Risk Assessments utilizing Quality Risk Management principles for activities pertaining to Product Protection Control.
• Provide timely, and accurate information for Annual Product Reviews, Quality System Reviews, Periodic Reviews, etc.
• Benchmark internally and externally; driving continuous improvement opportunities for IAPI with respect to Product Protection Control
• Be a key member participant during QA Inspections, with respect to Product Protection Control.
• Assess the impact proposed process changes and deviations may have on equipment cleaning and develop appropriate actions required to ensure cleaning remains effective and compliant.
• Prepare, review and approve (as required) Cleaning verification and/or validation protocols, summaries and assessments, Change Controls, Gate Review Presentations, readiness assessment documents, etc.

Basic Requirements:

• Bachelor's required in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Biology, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, or Engineering.
• At least 3 years of experience in cGMP manufacturing.

Additional Preferences:

• Preferred - Experience in a regulated environment and production equipment cleaning or frontline support.
• Acceptable - Experience in pharmaceutical or chemical manufacturing.
• Involvement in quality systems, root cause analysis and procedure and training development. Knowledge of cGMPs, equipment cleaning, quality systems, and interpretation of data.
• High-quality skills to include:
  • Teamwork and interpersonal, technical knowledge
  • Decision making
  • Multi-tasking
  • Ability to influence groups
  • Communication skills
  • Computer skills
  • Statistical analysis
  • Problem solving

• Skills include the following: leadership, multi-tasking, organization, problem-solving, teamwork/interpersonal, troubleshooting and communication. Computer proficiency with Microsoft Word, Excel and Power Point, and database management systems.

Other Information:

• Minimal Travel
• Day Shift. May require working off hours to achieve urgent business needs.
• No certifications required.
• Tasks require entering manufacturing areas which require wearing appropriate PPE.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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