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Scientist Jobs
Company | Eli Lilly and Company |
Address | Indianapolis, IN, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-08-29 |
Posted at | 9 months ago |
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.
- 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, PFDs, VMPs, 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.
- Understand the scientific principles required for manufacturing intermediates, bulk drug substance, and drug product including the interaction of the chemistry and equipment.
- 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.
- Provide support to the global and local Post Launch Optimization teams.
- Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Serve as technical mentor for TS/MS Scientists and PDTs, Managers and other disciplines.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
- Bachelor’s or equivalent in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry or Engineering.
- Relevant industrial experience (greater than 5 years) in any of the following associated disciplines such as Protein Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Regulatory, Development, or Administration.
- Technical/Scientific knowledge
- Multi-tasking
- Computer skills
- Ability to influence groups and communication skills
- Mentoring Leadership
- Decision making
- Good written and oral communications
- Problem solving
- Clear understanding of cGMPs
- Teamwork and interpersonal skills
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