Drug Product Analytical Chemistry Director - Synthetic Molecule Design And Development (Smdd)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and Drug Products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By encouraging a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients!

Our team is seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences and experience in Drug Product development to enable clinical trials, regulatory submissions, and new product commercialization for small molecule Drug Products (solid oral and/or parenteral formulations). This role offers the opportunity to lead Drug Product Analytical efforts within a multidisciplinary team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. 

Position Responsibilities:

Top candidates for this position will be encouraged to:

• Possess prior experience leading analytical efforts focused on pharmaceutical Drug Product development (e.g., solid oral dosage and/or parenteral formulations) 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 Product commercialization, including developing analytical methods, rationalizing specifications, designing stability studies, identifying impurities, assessing dose uniformity, and testing Drug Product performance characteristics (e.g., dissolution/disintegration).
• Drive the implementation of technical solutions and analytical strategies to enable formulation design, process engineering, and continuous manufacturing of Drug Products.
• Collaborate within project teams to deliver robust control strategies for 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.
• 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 lead 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.

BasicQualifications:

• Ph.D. in Analytical Chemistry or bioAnalytical Chemistry, or a related field with 7+ years of experience in the pharmaceutical industry after earning degree.
• M.S. in chemistry with 10+ years of experience in the pharmaceutical industry.
• B.S. in chemistry with 15+ years of experience in the pharmaceutical industry.

AdditionalSkills/Preferences:

• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Strong technical skills to enable innovation which creates business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience with management of a technical project.
• Demonstrated leadership capabilities especially in a team environment.
• Demonstrated ability to drive and accept change.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Additional Information:

• Travel: 0 to 10%
• Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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