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:
- 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 PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
- Develop, monitor, trend and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Understand, justify and document the state of process validation with data that evaluate the manufacturing process capability 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, SOPs and summary reports.
- 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 other TS/MS Scientists, PDTs or Managers of other disciplines.
- Support and/or lead technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
Basic Requirements:
- Bachelor's Degree in a Scientific Discipline; Chemistry, Biology, Pharmacy, Engineering or other STEM related field.
- Preference will be given to candidates in TS/MS, Production, Engineering, Quality Assurance, or Quality Control functions. Level will be commensurate with experience within the pharmaceutical manufacturing industry.
Additional Skills/Preferences:
- Responsible for maintaining a safe work environment.
- Ability to influence and lead diverse groups.
- Experience in statistics is preferred.
- Technical understanding, administrative and organizational skills.
- Builds relationships with internal functional partners.
- Demonstrated Project Management skills and ability to coordinate projects.
- Strong analytical and quantitative problem-solving skills.
- Ability to communicate and influence effectively across functional groups and stakeholders.
- Enthusiasm for changes, team spirit and flexibility.
- Must be able to meet project deadlines.
- Demonstrated ability to learn & apply technical/scientific knowledge.
Additional Information:
- Some off-shift work (night/weekend) may be required to support 24/7 operations.
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.