What are the responsibilities and job description for the Sr. Scientist / Principal Scientist – TSMS PAR position at Lilly?
Find out more about this role by reading the information below, then apply to be considered.
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.
Responsibilities :
The Scientist – TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role’s objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics / methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing.
Key Objectives / Deliverables :
- Support the assigned Process Team (formulation, filling, or VI) as TSMS representative.
- Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
- Represent Lilly Kenosha County TSMS team for internal and external communications on a regular basis.
- Lead risk management activities as it pertains to product / process.
- Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
- Prepare and Review or approve, as required, relevant technical documents such as : Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Identify opportunities and lead technical projects to improve process control and / or productivity.
- Serve as interface with upstream suppliers and parenteral product networks.
- Drive stability strategy for Lilly Kenosha County products.
- Provide Audit support as needed.
- Identify opportunities and participate in projects to improve process control and / or productivity.
Basic Qualifications :
Additional Skills / Preferences :
Additional Information :
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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