16459BR
Title Elanco R&D Biopharmaceutical Analytical Chemist
City Greenfield
State / Province Indiana
Position Locale Local / Onsite
Location Details Basel Switzerland or Greenfield, Indiana
Company Overview 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 3,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Responsibilities Role Overview
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.
Day to Day Responsibilities
* 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)
* 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 internal and external partners
* Provide guidance as Subject Matter Expert in global cross-functional project teams
* Deliver timely, high quality data and interpretations to drive key scientific solutions.
* Quickly become productive when assigned to new projects by effectively demonstrating mastery of complex new subject areas.
* Influence teams to undertake the right experiments to enable decision making in the shortest possible time. Identify critical limitations or flaws in scientific direction of previous work.
* Effectively execute role of representing one's discipline and effecting cross-functional integration on multi-disciplinary or cross functional team.
* Challenge current default practices and conventional wisdom and present effective or efficient alternatives for handling tasks in own primary areas of responsibility.
Basic Qualifications
* Ph.D. in Chemistry with 5-15 years of experience in pharmaceutical sciences
Additional Skills/Preferences
* A successful employee in this role would possess an understanding of analytical chemistry, analytical control strategy, product development, process chemistry and manufacturing controls, regulatory strategies, and have supervisory experience.
* 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.
* Excellent problem solving skills.
* Document results in consistent and timely manner to protect Elanco's intellectual property, and provide valuable information to others internally or externally, as needed, to meet regulatory requirements.
* Take project forward with speed, solving challenging scientific/technical/logistical problems along the way (balancing creativity/innovation with replication).
* Take on risky (i.e., technically challenging, political) problems and identify creative & alternative solutions - bring in new technology & leverage replication.
* Meet commitments and work effectively with others despite difficult and/or stressful conditions.
* Develop approaches or solutions that save time, increase efficiency, or otherwise directly impact ability to meet milestones.
* Minimize risks of rework or rejection by integrating compliance needs, including quality, regulatory, safety, etc., into designs, work plans, and work products.
* 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.
Additional Information
* Basel Switzerland or Greenfield, Indiana
* 10%25%20Travel and extensive telecommuting.
* Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
Removal Date 17-Jun-2015