Position Overview: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. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities. In this role, 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 sits at the intersection of late-phase analytical execution and cross-functional control strategy leadership, operating in one of the most scientifically complex and rapidly evolving therapeutic areas in our pipeline.
Position 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.
- Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas. Drive adoption of fit-for-purpose and novel analytical technologies that strengthen control strategy robustness for genetic medicine programs.
- Embrace diverse thought, background, and experience, and actively engage with the external environment to recognize and apply external innovation across the Lilly genetic medicine portfolio.
- 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.
Basic 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.
Additional Skills/Preferences:- 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.
- Ability to prioritize competing demands and operate effectively amid ambiguity.
Additional Information:- Travel: 0 to 15%
- Potential exposure to chemicals, allergens, and loud noises.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$148,500 - $257,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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