Director, Analytical Chemistry - Peptides

Position Responsibilities

• Possess prior experience leading analytical efforts focused on peptide drug substance and/or drug 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 peptide drug substance and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable formulation and drug product process design for peptide therapeutics.
• Collaborate within project teams to deliver robust control strategies for peptide drug products.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• 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; be able to use these techniques to bring value across a portfolio of peptide programs.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• 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.
• Collaborate closely with organizations across Discovery, 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 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15+ years (or M.S. in chemistry with 10+ years) of experience in the pharmaceutical industry.
• Experience with analytical and control strategy development for peptide drug substances and/or drug products.
• 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.

Additional Skills/Preferences

• 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.
• Able to prioritize multiple activities and manage ambiguity.
• Able to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.