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Principal Research Scientist-BioPharm Analytical Chemist
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.
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 feed additive enzyme products. The individual would also be responsible for support of development manufacturing campaigns including in-process controls and development of final release criteria, and would have general knowledge in enzyme product manufacturing science and processes. 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 enzyme candidate
Establishment of state-of-the-art validated analytical procedures for the characterization, release and stability testing of enzymes in compliance with regulatory standards (e.g. Food GMP)
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
Identify creative & alternative solutions to risky, complex problems and bring in new technology, while leveraging replication as appropriate
Challenge current default practices and conventional wisdom and present effective or efficient alternatives.
Ph.D. in Chemistry or Biochemistry with 5 or more years of experience in enzyme development
2 plus years of supervisory experience
Strong technical experience in relevant enzyme analytical techniques (e.g. enzymatic potency assays) and knowledge of innovative new analytical techniques
A successful employee in this role would possess an understanding of analytical chemistry, analytical control strategy, product development, bioprocess development and manufacturing controls and regulatory strategies
Knowledge of statistical and methodological concepts (e.g. DoE) to develop accurate, precise and robust enzyme assays
Strong interpersonal and intercultural skills (job requires significant customer/peer/management interaction on a global level) .
Excellent verbal and written communication skills.
Strong leadership skills, with the ability to participate in and facilitate decision-making.
Creativity, ability to think out-of the box
Excellent problem solving skills
Experience working across all phase of development from discovery through full commercialization.
Actively involved in professional organizations or in an external scientific network, (e.g., giving an external presentation, chairing a conference session, serving in an administrative capacity, or participating on a committee).
Maintain a reputation in the research community and leverage this reputation to build strategic relationships and to facilitate collaborations, research agreements, and outsourcing with world class external partners
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.