Analytical Chemistry Scientific Director - Synthetic Molecule Design and Development (SMDD) - Eli Lilly and Company

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 synthetic 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 synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. 

Position Responsibilities:

Scientists in this position will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes.  This will include, but not be limited to, developing analytical methods, establishing control strategies, and authoring technical reports and regulatory documents.  Top candidates for this position will be encouraged to:

• 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.

Basic Qualifications:

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with 8+ years of experience in the pharmaceutical industry after earning degree.

Additional Skills/Preferences:

• 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.

Additional Information:

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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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