Scientist - IAPI-TS/MS-PPC Micro

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.

Organization Overview

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Responsibilities

• Provides technical support for Contamination Control activities supporting Indianapolis API manufacturing.
• Prepare, review and approve (as required) relevant technical documents, such as: Change Controls, Events, Procedures, and Protocols pertaining to environmental monitoring and bioburden control and other contamination control related areas of focus.
• Collaborate with Frontline TS/MS to ensure appropriate execution of all Contamination Control deliverables, specifically with regards to environmental monitoring and bioburden control related activities. Provide assistance with process monitoring and data review, when necessary.
• Conduct and Author Risk Assessments utilizing Quality Risk Management principles for activities pertaining to Contamination 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 Contamination Control.
• Be a key member participant during QA Inspections, with respect to Contamination Control.
• Assess the impact proposed process changes and deviations may have on environmental monitoring and bioburden controls and develop appropriate actions required to ensure controls remain effective and compliant.
• Evaluate, and summarize environmental monitoring (EM) and utility data and trends for performance qualifications and periodic reviews.

Basic Requirements

• Bachelor’s in Microbiology, Biology or equivalent work experience
• 2+ year experience in quality systems, root cause analysis and procedure and training development.

Additional Preferences

• Experience in a regulated environment
• Experience in microbiology, water or environmental laboratories
• Knowledge of cGMPs, bioburden controls and measures, quality systems, statistical process control (SPC), interpretation of data and aseptic technique, and familiar with ISO Classifications.
• Skills include leadership, multi-tasking, organization, problem-solving, teamwork/interpersonal, troubleshooting and communication.
• Computer proficiency with Microsoft Word, Excel and Power Point, and database management systems.
• Teamwork and interpersonal, technical knowledge
• Ability to influence groups

Additional Information

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

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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