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

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 204,600; Full time

Benefits offered by this job

Comprehensive benefits program

Bonus eligibility

401(k) participation

Flexible spending accounts

Employee assistance program

Job summary

A leading pharmaceutical company in Indianapolis is seeking an experienced Advisor/Senior Advisor in Analytical Chemistry to lead the development of antibody-drug conjugates. This role requires strong analytical expertise, regulatory compliance knowledge, and the ability to collaborate across teams. Ideal candidates should possess a Ph.D. and exhibit exceptional problem-solving skills. The position offers a competitive salary and various benefits, fostering a diverse work environment.

Qualifications

• Experience in pharmaceutical industry with analytics.
• Strong expertise in method validation and impurity profiling.
• Demonstrated adaptability in fast-paced environments.

Responsibilities

• Develop and validate analytical methods for ADCs.
• Collaborate within project teams to establish drug controls.
• Contribute to regulatory submissions and inspections.

Skills

Analytical techniques (HPLC, CE, GC, LC/MS)

Leadership

Regulatory compliance knowledge

Collaboration

Scientific problem-solving

Education

Ph.D. in analytical chemistry or related field

M.S. with 8+ years of experience

B.S. with 12+ years of experience

Job description

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

Join to apply for the Advisor/Senior Advisor, Analytical Chemistry -Antibody-Drug Conjugates role at BioSpace.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first. We’re looking for people determined to make life better around the world.

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 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 or Senior Advisor to support the development of antibody‑drug conjugates (ADCs), with a focus on linker‑payload intermediate and/or conjugated drug substance/product. 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 linker‑payload components and/or conjugated drug substance/product; establish specifications, characterize impurities and degradation pathways, and support comparability and stability studies.
• Lead lab activities on method development and analytical testing to support process development of linker‑payload component and/or conjugated mAb.
• Collaborate within project teams to deliver robust control strategies for drug substances and drug products and/or linker payload intermediates.
• Drive implementation of analytical solutions and strategies to enable synthetic chemistry and process engineering needed to enable ADC linker‑payload development and manufacturing.
• Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and drug product development of antibody‑drug conjugates, and 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., organic chemistry and/or large molecule analytics, pharmaceutical sciences, PAT).
• Contribute to regulatory submissions (CTD authoring, NDA/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, organic chemistry, or a related field with 3+ years of experience in the pharmaceutical industry; OR M.S. with 8+ years; OR B.S. with 12+ years of relevant industry experience.
• Proven leadership in CMC analytical development for linker‑payloads/small molecule therapeutics or therapeutic biologics drug.
• Strong expertise in analytical techniques such as HPLC, CE, GC, IC, 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: 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JIL N), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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.