Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Responsibilities Through application of scientific training and relevant experience, the individual will be responsible for working with a team of scientists to develop a phase-appropriate analytical control strategy to support the development and commercialization of new biopharmaceutical drug candidates. The individual would also be responsible for support of manufacturing campaigns including in-process controls and development of final release criteria, and would have general knowledge in biopharmaceutical drug substance and drug product manufacturing science. The individual would also be responsible to support global regulatory submissions.
- Design analytical studies to establish a detailed understanding of bio- and physicochemical properties of the drug candidate
- Establishment of state-of-the-art validated analytical procedures for the characterization, release and stability testing of biopharmaceuticals in compliance with regulatory standards (e.g. GMP)
- Transfer of analytical procedures
- Preparation, review and approval of operational, quality-relevant and regulatory-relevant documentation
- Analytical Subject Matter Expert for investigations and the maintenance of local and global quality systems (e.g. Standard operating procedures)
- Serve as Analytical Project Lead with both internal and external partners
- Provide guidance as Subject Matter Expert in global cross-functional project teams
- Planning and oversight of external service lab activities
- Ph.D in chemistry or related scientific disciplines with 3 years of industry experience in biopharmaceuticals or;
- Master degree in chemistry or related scientific disciplines with 10 years of industry experience in biopharmaceuticals.
- A successful employee in this role would possess an understanding of analytical chemistry, analytical control strategy, product development, bioprocess development and manufacturing controls, regulatory strategies, and have supervisory experience.
- Strong technical experience in relevant biopharmaceutical analytical techniques (e.g. SEC, RPHPLC, IEX, HIC, CE, CE-SDS).
- Strong interpersonal and intercultural skills (job requires significant customer/peer/management interaction on a global level) .
- Excellent verbal and written communication skills.
- Scientific leadership skills, with the ability to participate in cross-functional team work
- Troubleshooting and problem solving skills.Experience with various analytical instrumentation and software for physicochemical characterization and bioassay of biological drugs
- Experience working under regulated standards (GxP)
- Experience with Design of Experiments, Statistical evaluation, stability prediction tools
- Proven experience of systematic methodology for analytical method development of biological molecules
- Reports to: Director Pharmaceutical Sciences and Technology -Analytical Development
- Direct reports: NoneGreenfield, Indiana
- 10-25%% Travel and extensive telecommuting.
- If you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4.
- 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.