- 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 knowledge
- Decision making
- Multi-tasking
- Ability to influence diverse groups via technical understanding and excellentcommunication skills
- Make appropriate and timely decisions while identifying and solving problems
- Computer skills
- Problem solving
- Teamwork and interpersonal skills
- Clear understanding of cGMPs
- Mentoring Leadership
- Good written and oral communications
- Advanced 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
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 ( ) 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.
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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly -
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TSMS Representative - Indianapolis, United States - Eli Lilly and Company
Description
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:
