Director - BRD Analytical Development

Position Summary We are seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences and experience in pharmaceutical development to enable clinical trials, regulatory submissions, and new product commercialization. This role offers the opportunity to lead drug substance and/or drug product analytical efforts within a multidisciplinary team while offering access to world‑class capabilities for pharmaceutical development. Responsibilities Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, and demonstrate familiarity with regulatory requirements and emerging industry trends. Demonstrate depth of knowledge in 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 drug substance and drug product process design. Collaborate with project teams to deliver robust control strategies for drug substances, drug products, and/or intermediates. 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 apply effective scientific concepts across multiple subject areas, bringing value across peptides, oligonucleotides, monoclonal antibodies, gene therapy, and bioconjugate modalities. Mentor and develop scientific staff; encourage growth, excellence, and knowledge sharing. Introduce new methodologies for optimization of existing modalities or development of control strategies for new modalities. Plan and manage short‑term and long‑term development activities; develop technical agendas and timelines; recommend resource allocation; communicate progress and propose changes. Collaborate closely with Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions. Embrace diverse thoughts, backgrounds, and experiences to deliver innovative solutions. Possess strong communication, organizational, and leadership skills. Actively engage in the external environment and recognize external innovation across Lilly’s synthetic portfolio. Basic Requirements (Qualifications) Ph.D. in Analytical Chemistry or Bioanalytical Chemistry with 5+ years of pharmaceutical industry experience after graduation; or B.S. in Chemistry with 15+ years; or M.S. in Chemistry with 10+ years. Prior experience leading analytical efforts for drug substance and/or drug product development and commercialization, familiarity with emerging industry trends, and introduction of new methodologies. Experience developing global regulatory strategies, authoring regulatory submissions, responding to regulatory questions, and registering products across global markets. Experience managing technical projects; providing guidance for external network analytical activities; ensuring methods are sound and fit‑for‑purpose; executing technology transfer to CRO/CMO and Lilly manufacturing sites. Strong communication, organizational, and leadership skills; ability to drive and accept change. Experience mentoring and developing scientific staff; encouraging growth and knowledge sharing; demonstrated leadership capabilities. Additional Preferences Strong technical skills enabling innovation that creates business value. Creativity and ability to transform ideas into marketable products and processes. Demonstrated success in persuasion, influence, and negotiation. Good interpersonal skills and collaboration tendencies. Ability to prioritize multiple activities and manage ambiguity. Ability to influence others to promote a positive work environment. Technical proficiency and ability to generate future‑focused ideas. Additional Information Travel: 0–15% Potential exposure to chemicals, allergens, and loud noises. Position is onsite: Indianapolis, IN; Lilly Technology Center‑North (LTC‑N). Physical Demands / Travel The physical demands of this job are consistent with a laboratory environment. Work Environment Laboratory setting. Compensation and Benefits Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage range for this position is $139,500 – $217,800. Full‑time employees may be eligible for a company bonus and a comprehensive benefit program, including 401(k) participation, pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, leave of absence, and well‑being benefits (employee assistance program, fitness and club activities). #J-18808-Ljbffr