Advisor / Senior Advisor, Analytical Chemistry - Antibody-Drug Conjugates

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly is seeking an experienced CMC Analytical Chemistry Advisor to advance ADC development at the Indianapolis site. You will lead analytical development for ADC drug substances and products, collaborate across chemistry, formulation, and engineering teams, and contribute to regulatory submissions.

The role emphasizes leadership in analytical strategy, transfer to manufacturing or CROs/CMOs, and staying abreast of evolving industry guidelines in a fast-paced setting.

Qualifications

• Ph.D. in Analytical Chemistry or related STEM with 3+ years in pharma, or MS with 8+ years, or BS with 10+ years.
• Proven leadership in CMC analytical development for therapeutic biologics.
• Strong expertise in HPLC, LC/MS, CE, impurity profiling, and method validation.
• Familiar with ICH guidelines and regulatory requirements.

Responsibilities

• Develop and validate analytical methods for ADC conjugated drug substance/drug product.
• Lead lab activities on purity/impurity method development and analytical testing.
• Deliver robust control strategies for ADC drug substances, drug products, and mAb intermediates.
• Provide technical oversight for analytical development and tech transfer to CROs/CMOs.
• Support regulatory submissions (IND, BLA) and responses to RtQs.
• Mentor scientific staff and manage development timelines and resources.
• Collaborate with cross-functional teams including process chemists and formulation scientists.

Skills

HPLC

LC/MS

CE

Impurity profiling

Method validation

Analytical problem-solving

Leadership

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

BS in Analytical Chemistry

Job description

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.

Organization Overview

The Bioproduct Research and Development (BR&D) organization delivers innovative medicines through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, antibody-drug conjugates (ADCs), novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep scientific expertise that collaborates closely with discovery and manufacturing partners. Located in Indianapolis, IN, our scientists have access to world-class pharmaceutical development and engineering capabilities.

In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms. Ideal candidates will possess experience across multiple analytical techniques and demonstrate an aptitude in technical problem-solving and be motivated to work both independently and collaboratively in a dynamic environment.

We are seeking an experienced, innovative, and motivated CMC Analytical Chemistry Advisor to support the development of antibody-drug conjugates (ADCs), with a focus on conjugated drug substance/drug product. In this role, you will lead the analytical development work within a cross-functional team including process chemists, formulation scientists, and engineers.

Key Responsibilities

• Develop and validate analytical methods for ADC conjugated drug substance/drug product; establish control strategy, specifications, characterize impurities and degradation pathways, and support comparability and stability studies.
• Lead lab activities on purity/impurity method development and analytical testing to support conjugation process development.
• As CMC analytical lead, collaborate within project teams to deliver robust control strategies for ADC drug substances and drug products and mAb intermediates.
• Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and drug product development of antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry. Provide technical oversight for analytical development work executed internally and by external partners (CROs/CMOs); ensure sound method development, characterization, and successful technology transfer.
• Demonstrate strong technical skills, learning agility and the ability to apply scientific principles across multiple domains (e.g., large molecule analytics, pharmaceutical sciences).
• Contribute to regulatory submissions (IND authoring, BLA filings), support pre-approval inspections (PAI), and respond to regulatory agency questions (RtQs).
• Mentor and develop scientific staff; support continued professional growth, knowledge sharing, and technical excellence.
• Plan and manage both short- and long-term development activities; define project timelines, allocate resources, monitor progress, and adjust plans as needed.
• Partner with development and manufacturing teams to provide clinical and regulatory deliverables.
• Promote an inclusive culture by embracing diverse perspectives and encouraging innovation.
• Engage externally to identify and apply relevant advances in analytical chemistry and drug development.

Basic Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 3+ years of experience in the pharmaceutical industry; OR
• M.S. in Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 8+ years of experience in the pharmaceutical industry; OR
• B.S. in Analytical Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM degree with 10+ years of experience in the pharmaceutical industry.
• Proven leadership in CMC analytical development for therapeutic biologics drug.
• Strong expertise in analytical techniques such as HPLC, CE, LC/MS, impurity profiling/structure elucidation, and method validation.
• Familiarity with ICH guidelines, regulatory requirements and evolving industry trends.

Additional Preferences

• Experience transferring analytical methods into manufacturing environments.
• Background in global regulatory strategy, including submission authoring and product registration.
• Technical innovation skills with the ability to translate concepts into a process that can be used for commercialization.
• Experience managing technical projects and leading scientific teams.
• Demonstrated adaptability, influence, and collaboration across functions.
• Strong communication (oral and written), organizational, and leadership skills.
• Ability to manage competing priorities and operate effectively in ambiguous environments.

Additional Information

• Travel Requirement: 0-10%
• Location: Onsite, working in Indianapolis, IN at 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 $126,000 - $204,600. 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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