Analytical Chemistry Scientific Director - Synthetic Molecule Design and Development (SMDD)
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Possess prior experience leading analytical efforts within an innovator organization focused on pharmaceutical product development and commercialization, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
- Demonstrate a depth of knowledge in concepts relevant to drug substance or drug product commercialization, including, for example, developing analytical methods, supporting specifications, designing stability studies, establishing starting material rationales for synthetic processes, identifying impurities, and testing drug product performance characteristics (e.g., dissolution/disintegration).
- Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
- Collaborate within project teams to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
- Have experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
- Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
- Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
- Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
- Plan and run short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate closely with organizations across development and manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
- Embrace diverse thought, background, and experience to deliver innovative solutions.
- Possess strong communication (oral, written), organizational, and leadership skills.
- Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.
- Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with 8+ years of experience in the pharmaceutical industry after earning degree.
- Significant experience developing pharmaceutical products within an innovator organization, authoring regulatory documentation, and overseeing CMO/CRO activities.
- Demonstrated leadership capabilities, especially in a cross-functional team environment.
- Strong technical skills to enable innovation which creates business value.
- Experience with technical transfer of analytical methods into manufacturing operations.
- Creativity and ability to transform ideas into marketable products and processes.
- Knowledge and experience with management of a technical project.
- Demonstrated ability to drive and accept change.
- Good interpersonal skills and a sustained tendency for collaboration.
- Demonstrated success in persuasion, influence, and negotiation.
- Ability to prioritize multiple activities and handle ambiguity.
- Ability to influence others to promote a positive work environment.
- Demonstrated technical proficiency and ability to create ideas for future work plans.
- Travel: 0 to 10%
- Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)