- Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
- Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
- Develop and monitor established 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.
- Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Ensure that experiments are well designed with clear objectives.
- Ability to analyze data and ensure appropriate documentation.
- Write technical reports and documents.
- Bachelors in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or Master's Degree and 1 year experience in cGMP manufacturing.
- Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.
- Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
- Familiarity with cGMP manufacturing environment and terminology.
- Excellent analytical, interpersonal, written and oral communication skills.
- Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
- Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
- Guidance/mentoring of others through processes.
- Flexibility to meet business needs.
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Manufacturing Scientist - Lebanon, United States - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations.
Organization Overview:
The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
Responsibilities:
Basic Requirements:
Additional Preferences:
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.
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