Principle Research Scientist for CMC Leader

Lilly is a global health care leader that unites caring with discovery to make life better for people around the world. For more than a century, we have stayed true to a core set of values—excellence, integrity, and respect for people—that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

The Portfolio Design and Integration group is responsible for developing the portfolio strategy and for the application of the technical capabilities to the portfolio. Through scientific training and relevant experience, a team of scientists and team leaders support the portfolio from early clinical development through the commercialization of new drug candidates. Teams of cross functional scientists will drive integration of technical elements from internal and external groups enabling the clinical manufacturing and commercialization of new drug candidates.

* Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and provides leadership in the establishment and maintenance of SMDD Quality systems. * Contributes to, leads and/or supervises the formulation, process development and/or control strategy of drug substance and/or drug product. Typical responsibilities include: * Development of the manufacturing processes and control strategies for drug substance and/or drug product. * Preparation of the appropriate manufacturing and controls portion of the IND/CTX and preparation of information for annual updates. * Scale-up to manufacturing. * Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions. * Provides advice and guidance to teams on the development of a commercial development strategy. * Authors, reviews or approves high quality technical reports and regulatory submissions dealing with the work performed by the department. Ensures that records and technical notebooks are adequately maintained. * Demonstrates the ability to provide technical guidance and oversight to development work being executed at collaboration partners, and to integrate data and information into overall control strategy and regulatory documents. * Demonstrates the Lilly Leadership behaviors, as defined in the Lilly Performance Management system * Plans and manages short term and long term development activities. Assigns work to be done, coordinates, evaluates, and reviews the activities of personnel assigned to the group. * Develops or reviews plans and timetables for project work. Recommends the resource allocation to accomplish projects according to plans, communication progress, and proposes changes in project timelines, objectives, or direction. * Helps ensure that people, and their environment are safe and that company policies concerning safety are followed.

**Basic Qualifications** * Ph.D. Chemistry (analytical preferred) with 12+ years of experience in the pharmaceutical development field. Or * B.S. or M.S.in chemistry with 17+ years of experience in pharmaceutical development field. **Additional Skills/Preferences** * Broad, technical knowledge of those areas needed for development of new pharmaceutical products. * Creativity, imagination, and ability to transform ideas into marketable products and processes. * Sufficient knowledge to effectively interact with quality control, production, process, engineering, and regulatory agencies. * Demonstrated ability to drive and accept change. * Strong technical skills to supply business value. * Knowledge and experience in project management. * Demonstrated leadership capabilities especially in a team environment. * Good interpersonal skills and demonstrated collaborative abilities. * Demonstrated success in persuasion, influence, and negotiation skills. * Good verbal and written communication skills. * Preferred experience with manufacturing / process support. * Ability to prioritize multiple activities and manage ambiguity. * Influence others to promote a positive work environment. * Demonstrated initiative and risk taking. * Demonstrated technical proficiency and ability to create ideas for future work plans.