Advisor / Senior Advisor, Analytical Sciences - Extractables & Leachables and External Partner Strategy

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

Lilly’s Bioproduct Research and Development (BR&D) organization develops and commercializes medicines across modalities including insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, genetic medicines, and vaccines. This role provides scientific leadership for extractables and leachables (E&L) and elemental impurities across Lilly’s modalities, presentations, and manufacturing systems, and serves as the technical liaison between BR&D Analytical and external CDMO and contract laboratory partners. The position helps assure the safety and quality of medicines from early development through commercialization, represents Lilly with global regulators and industry bodies, and builds an external network that complements internal analytical capabilities.

The role coordinates E&L and elemental impurity strategies, provides scientific oversight of externally executed testing, and works with commercial manufacturing sites and technical organizations on regulatory readiness, implementation, and lifecycle activities. It also provides leadership for container closure systems and supports integration of digital tools and AI into E&L workflows. The position is based at Lilly Technology Center-North in Indianapolis, Indiana. Travel is 10% possible. There may be exposure to chemicals, allergens, and loud noises.

Requirements

• Ph.D. in analytical chemistry, pharmaceutical sciences, or a related field and at least 5 years of pharmaceutical industry experience after earning the degree; alternatively, a B.S. in chemistry and at least 15 years of pharmaceutical industry experience, or an M.S. in chemistry and at least 10 years.
• In-depth experience in E&L strategy, study design, and safety/toxicological risk assessment for late-stage and commercial pharmaceutical or biologic products.
• Experience with elemental impurity risk assessment and control strategies, including ICP-MS for elemental analysis.
• Experience leading E&L laboratories, external partner relationships, and/or technical projects at a pharmaceutical company, CDMO, or contract laboratory.

Nice To Haves

• Experience developing global regulatory strategies, including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Demonstrated technical expertise in E&L across multiple modalities, container closure systems, device materials, and/or single-use manufacturing systems.
• Demonstrated external influence in the E&L field through industry consortia, standards committees, scientific conferences, or regulatory engagement.
• Strong scientific and strategic thinking, with the ability to translate technical expertise and new technologies into innovative solutions and future strategies that create business value.
• Demonstrated cross-functional leadership and collaboration, with the ability to influence, negotiate, and build alignment across internal SMEs, global commercial sites, senior leaders, and external partners.
• Strong project and organizational skills, including prioritizing multiple programs, managing external partnerships and timelines, navigating ambiguity, and adapting to change.
• Strong interpersonal and communication skills, with a commitment to collaboration, knowledge sharing, and a positive work environment.

Responsibilities

• Provide strategic leadership for E&L and elemental impurities across modalities, presentations, and manufacturing systems, partnering with internal subject-matter experts to establish robust, risk-based strategies.
• Coordinate end-to-end E&L and elemental impurity strategies, including risk assessment, phase-appropriate requirements, analytical approaches, and control strategies aligned with regulatory expectations.
• Provide scientific oversight of externally executed testing, including study design, protocols, data interpretation, technical reports, and external laboratory capabilities.
• Partner with global commercial manufacturing sites and technical organizations to implement E&L and elemental impurity strategies for BLA/NDA readiness, site implementation, and post-approval lifecycle activities.
• Lead regulatory and lifecycle strategies for E&L and elemental impurities, including submissions, health authority responses, investigations, and regulatory commitments.
• Provide strategic leadership for container closure systems and best practices, including analytical control strategy, container closure integrity, component compatibility, standards, and knowledge sharing.
• Advance integration of digital tools and AI into E&L workflows to improve efficiency, data utilization, and scientific decision-making, and contribute to or lead relevant digital initiatives.

Benefits

• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision, and prescription drug benefits
• Flexible benefits, such as 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, such as an employee assistance program, fitness benefits, and employee clubs and activities
• Company bonus, depending in part on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior