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

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Job summary

Lilly in Indianapolis, IN seeks an experienced scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across all modalities, serving as the liaison between BR&D Analytical and external CDMO partners. This role shapes safety and quality decisions from development through commercialization and engages with global regulators and industry bodies.

The position emphasizes leadership across modalities, regulatory submissions, and lifecycle strategies, with a

Qualifications

• Ph.D. in analytical chemistry, pharmaceutical sciences, or related field with 5+ years of pharma industry experience.
• 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.

Responsibilities

• Provide strategic leadership for E&L and elemental impurities across modalities and manufacturing systems.
• Coordinate end-to-end E&L and elemental impurity strategies, including risk assessment and regulatory-aligned control strategies.
• Provide scientific oversight of externally executed testing, including study design and data interpretation.
• Partner with global manufacturing sites to enable implementation of E&L strategies for readiness and lifecycle activities.
• Lead regulatory and lifecycle strategies for E&L and elemental impurities, including submissions and health authority responses.
• Provide strategic leadership for container closure systems and best practices, including analytical control strategy and compatibility.
• Advance integration of digital tools and AI into E&L workflows to improve efficiency and decision-making.

Skills

E&L strategy

Regulatory strategy

External partner management

Cross-functional leadership

Data interpretation

Digital tools & AI

Education

Ph.D. in analytical chemistry or related field

5+ years pharma industry experience

Tools

ICP-MS

Job description

Company Overview

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

BR&D 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, genetic medicines, and vaccines. 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.

Role Overview

In this role, we are seeking an experienced, innovative, and influential scientific leader to set the extractables and leachables (E&L) and elemental impurities strategy across all of Lilly's modalities, and to serve as the technical liaison between BR&D Analytical and its external CDMO and contract laboratory partners. This role offers the opportunity to shape how Lilly assures the safety and quality of its medicines from early development through commercialization, to represent Lilly with global regulators and industry bodies, and to build a resilient external network that complements Lilly's internal analytical capabilities.

Position Responsibilities

• Provide strategic leadership for E&L and elemental impurities across modalities (including peptides, oligonucleotides, conjugates, monoclonal antibodies, genetic medicines, and vaccines) and across presentations and manufacturing systems (vials, prefilled syringes, devices, and single-use systems), partnering closely with internal SMEs 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 enable implementation of 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; contribute to or lead relevant digital initiatives.

Basic Qualifications

• Ph.D. in analytical chemistry, pharmaceutical sciences, 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.
• 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.

Additional Skills/Preferences

• 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, with experience 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, with demonstrated ability to prioritize multiple programs, manage external partnerships and timelines, navigate ambiguity, and adapt to change.
• Strong interpersonal and communication skills, with a demonstrated commitment to collaboration, knowledge sharing, and a positive work environment.

Additional Information

• Travel: 10%
• Possible exposure to chemicals, allergens, and loud noises.
• Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $211,200

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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