Director, Analytical Chemistry – Genetic Medicines; Analytical Development - BR&D

About the role

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and genetic medicines systems. Scientists in this role have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

Responsibilities

• Possess prior experience leading analytical efforts focused on genetic medicine (e.g., AAV-based gene therapy, gene editing, cell-based gene therapy, and RNA-based therapies) drug substance and 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 genetic medicine 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 process development and product understanding, delivering robust control strategies for genetic medicine drug substance and drug products.
• Collaborate within project teams, partner organizations, and across Discovery, Development, and Manufacturing to deliver material and information for clinical trials and regulatory submissions.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• Monitor and assess emerging regulatory guidance and precedents to proactively shape Lilly's regulatory strategy for ATMP programs.
• 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.
• 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 including developing/reviewing 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.
• Possess strong communication (oral, written), organizational, and leadership skills.

Qualifications

• Ph.D. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology with 5+ years of experience in the pharmaceutical industry after earning degree; or
• M.S. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology; with 10+ years of relevant pharmaceutical or biotech industry experience; or
• B.S. in Analytical Chemistry, Molecular Biology, Biochemistry, or Biology; with 15+ years of relevant pharmaceutical or biotech industry experience.
• Demonstrated experience with analytical control strategy development for late-phase genetic medicine drug substances and drug products is required in a pharmaceutical or biotech development context.
• Prior experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets in a pharmaceutical or biotech development context.
• Experience with technical transfer of analytical methods into internal or external GMP manufacturing facilities in a pharmaceutical or biotech development context.

Skills

• Strong technical depth that translates scientific innovation into measurable business value and a forward-looking approach to shaping future work plans.
• Proven experience managing complex technical projects from planning through delivery.
• Demonstrated leadership in collaborative, cross-functional team environments, with the ability to drive change and adapt quickly in a dynamic environment.
• Strong persuasion, influencing, and negotiation skills.
• Excellent interpersonal skills with a consistent orientation toward collaboration and fostering a positive, inclusive work environment.
• Able to prioritize competing demands and operate effectively amid ambiguity.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $148,500 - $257,400

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).