Senior Advisor, Analytical Chemistry - Antibody-Drug Conjugates Linker Payload Development BR&D

Lilly; Indianapolis (IN); Presencial; USD 129 000 - 211 000; Tempo integral

Resumo da oferta

Lilly in Indianapolis, IN, is seeking a Senior Advisor of Analytical Chemistry for Antibody-Drug Conjugates Linker Payload Development to lead analytical development efforts for ADC programs and to enable clinical trials and regulatory submissions. The role requires a Ph.D. with 3+ years or an M.S.

with 8+ years or a B.S. with 12+ years in pharmaceutical science, with strong skills in LC-MS, HPLC, impurity profiling, and method validation, plus cross‑functional leadership and a drive for

Qualificações

• Ph.D. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 3+ years in pharmaceutical industry.
• M.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 8+ years in pharmaceutical industry.
• B.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 12+ years in pharmaceutical industry.
• Proven leadership in CMC analytical development for linker‑payloads/small molecule therapeutics or synthetic molecules.
• Strong expertise in analytical techniques such as IR, HPLC, GC, IC, LC/MS, KF, impurity profiling/structure elucidation, and method development, qualification/validation.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

Responsabilidades

• Lead analytical development and commercialization for the drug-linker intermediate used in ADCs, including method development, qualification/validation, specification-setting, impurity/degradation characterization, reference standard management, and stability studies.
• Author technical reports and regulatory submissions and respond to health authority questions on analytical topics (IND/CTA, BLA/NDA/MAA).
• Collaborate with project teams to establish robust control strategies for linker-payload intermediates and process impurities.
• Drive technical and analytical strategies enabling linker-payload intermediate and conjugated DS/DP process design.
• Provide technical oversight for external analytical work; lead technology transfer to CRO/CMO partners and internal Lilly sites.
• Mentor and develop team members, fostering technical growth and knowledge sharing.
• Introduce new analytical methodologies to advance ADC development and manufacturing.
• Plan and manage development timelines and resourcing; communicate progress and adjust plans.
• Partner across Discovery, Development, and Manufacturing to deliver materials and data for clinical trials and regulatory filings.

Conhecimentos

IR spectroscopy

HPLC

GC

IC

LC-MS

KF

Impurity profiling

Structure elucidation

Method development

Method qualification

Validation

CMC leadership

Regulatory submissions

Tech transfer

Formação académica

Ph.D. in Analytical/Organic Chemistry or related field

M.S. in Analytical/Organic Chemistry or related field

B.S. in Analytical/Organic Chemistry or related field

Descrição da oferta de emprego

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 new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy 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 offers the opportunity to lead analytical development efforts focused on delivery of linker payload intermediate for antibody‑drug conjugates within a multidisciplinary team while offering access to word‑class capabilities for pharmaceutical development.

As a Senior Advisor of Analytical Chemistry for Antibody‑Drug Conjugates Linker Payload Development, you will play a pivotal role in driving innovation and ensuring scientific excellence within Lilly's development pipeline. You will be expected to foster interdisciplinary collaboration, leveraging cross‑functional expertise to advance both early and late‑stage ADC programs. Your leadership will influence strategic decision‑making and contribute to Lilly’s mission to transform patient outcomes worldwide.

Position Responsibilities

Top candidates for this position will be expected to:

• Lead analytical development and commercialization efforts for the drug‑linker intermediate used in antibody‑drug conjugates (ADCs), including method development, qualification/validation, specification‑setting, impurity/degradation characterization, reference standard management, and stability studies.
• Author technical reports and CMC sections for regulatory submissions and respond to health authority questions on analytical and product quality topics (IND/CTA, BLA/NDA/MAA, and country‑specific RtQs).
• Collaborate with project teams to establish robust control strategies for linker‑payload intermediates and process impurities, applying deep technical knowledge across linker/payload, mAb, and drug substance/product development.
• Drive technical and analytical strategies enabling linker‑payload intermediate and conjugated DS/DP process design.
• Provide technical oversight for external analytical work, ensuring methods are scientifically sound and fit‑for‑purpose; lead technology transfer to CRO/CMO partners and internal Lilly sites.
• Mentor and develop team members, fostering technical growth and knowledge sharing.
• Introduce new analytical methodologies to advance ADC development and manufacturing.
• Plan and manage development timelines and resourcing; communicate progress and adjust plans as needed.
• Partner across Discovery, Development, and Manufacturing to deliver materials and data for clinical trials and regulatory filings.
• Bring strong communication, organizational, and leadership skills, and stay engaged with external innovation relevant to the ADC portfolio.

Basic Qualifications

• Ph.D. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 3+ years of relevant experience in the pharmaceutical industry experience; or
• M.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 8+ years of relevant experience in the pharmaceutical industry experience; or
• B.S. in Analytical Chemistry, Organic Chemistry, or a closely related STEM field with 12+ years of relevant pharmaceutical industry experience.
• Proven leadership in CMC analytical development for linker‑payloads/small molecule therapeutics or synthetic molecules.
• Strong expertise in analytical techniques such as IR, HPLC, GC, IC, LC/MS, KF, impurity profiling/structure elucidation, and method development, qualification/validation.
• Experience with technical transfer of analytical methods into manufacturing operations.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.

Additional Skills/Preferences

• Strong technical skills that translate into business value and innovation.
• Experience with control strategy implementation for linker‑payloads or small molecules.
• Effective project management.
• Strong communication skills and ability to provide cross‑functional leadership.
• Comfort managing multiple priorities.
• Demonstrated ability to drive change and generate creative, scientifically sound ideas for future work.

Additional Information

• Travel: 0 to 15%.
• Potential exposure to chemicals, allergens, and loud noises.
• Position is local and work is onsite 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

$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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