Director - Analytical Chemistry

Eli Lilly and Company • Us, IN

19h • Onsite

About The Position

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, antibody-drug conjugates (ADCs) and other emerging therapeutic modalities. By fostering 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. SMDD 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 is a hands-on technical leadership role where you will lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers, while directly managing a small technical team of analytical scientists. The position offers access to world-class capabilities for pharmaceutical development and requires a balance of deep technical expertise with people leadership. This is a unique opportunity to shape the future of pharmaceutical development across multiple cutting-edge modalities while building a distinguished career at a company where your analytical expertise will directly accelerate life-changing therapies to patients worldwide.

Requirements

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with >8 years of experience in the pharmaceutical industry after earning degree.
• Project/technical leadership experience within an innovator organization focused on pharmaceutical product development and commercialization with specific focus on small molecules, synthetic peptides, oligonucleotides, and/or the payload-linker elements of ADCs, ARCs, etc.
• Demonstrated familiarity with applicable regulatory requirements and emerging trends in the industry.

Nice To Haves

• Strong technical skills to enable innovation which creates business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Demonstrated ability to drive and accept change.
• Proven ability to influence, persuade, and negotiate effectively to drive alignment and promote a positive, collaborative work environment.
• Ability to prioritize multiple activities and manage ambiguity.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Responsibilities

• Technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes.
• Mentoring and developing direct reports.
• Hands-on technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes, while mentoring and developing their direct reports.
• Developing analytical methods, justifying specifications, designing stability studies, establishing starting material rationales for synthetic processes, identifying impurities, and testing drug product performance characteristics (e.g., dissolution/disintegration).
• Drive hands-on 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).
• 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).
• Directly manage, mentor, and develop a small team of analytical scientists (typically 2-4 direct reports).
• Ensure continued technical and professional growth of team members, encourage efforts towards excellence and knowledge sharing, and provide day-to-day technical guidance on analytical projects.
• Plan and manage 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.
• Excel in communication, leadership, and collaboration—embracing diverse perspectives to drive innovative solutions across multidisciplinary teams.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree