TSMS Representative

4 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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:
The Technical Services / Manufacturing Science (TS/MS) scientist will support commercial drug substance manufacturing on a peptide platform. This position will be involved in preparation and execution of aspects ranging from equipment qualification, data monitoring, support of Master Production Records, process validation, and frontline technical support of routine production.

Responsibilities:

Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Ensure that an accurate instruction set (tickets & procedures) and process flow document  describe the process as performed and the control strategy for the discrete manufacturing steps. Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose. Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, validation master plans, , etc. Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.Serve as technical mentor for TS/MS Scientists and Specialists, as well as other process team members from other disciplines.Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.Provide support to the global and local PLOT teams.Monitor key performance indicators (KPIs) and update the process team huddle board
Basic Requirements:Bachelor’s or equivalent in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry or Engineering.
Additional Skills/Preferences:Relevant industrial experience is preferred in any of the following associated disciplines such as Protein Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Regulatory, Development, or Pharmaceutical Manufacturing.Technical/Scientific knowledgeDecision makingMulti-taskingAbility to influence diverse groups via technical understanding and excellentcommunication skillsMake appropriate and timely decisions while identifying and solving problemsComputer skillsProblem solvingTeamwork and interpersonal skillsClear understanding of cGMPsMentoring LeadershipGood written and oral communicationsAdvanced data modeling experience
Additional Information:
[The items included in this section should include additional items you wish to share about this position. The bulleted list could contain the following:
• Travel: less than 5%
• Shift information: Night Shift, 3-3 (Three days working - three days off work)
• Position location: Indianapolis
 

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