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

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 126 000 - 205 000; Plein temps

Avantages offerts par ce poste

Company bonus

Comprehensive benefits

Résumé du poste

Lilly in Indianapolis, IN seeks an Advisor / Senior Advisor of Analytical Chemistry for linker payloads of Antibody-Drug Conjugates. You will lead analytical development for linker payload intermediates and support regulatory submissions in a multidisciplinary team.

This role requires strong leadership, cross-functional collaboration, and experience in transferring methods to CROs/CMOs, with responsibility across early and late-stage ADC programs.

Qualifications

• Ph.D./M.S./B.S. with pharma experience per the stated degrees.
• Experience in CMC analytical development for linker-payloads or small molecules.
• Proven ability to author regulatory submissions and respond to regulatory questions.

Responsabilités

• Lead analytical efforts for linker payload intermediates in ADC programs.
• Develop and qualify analytical methods; establish specifications and impurity profiles.
• Transfer methods to CRO/CMO and Lilly sites; support IND/CTA and regulatory filings.
• Collaborate across Discovery, Development, and Manufacturing to enable trials.

Connaissances

Analytical methods

Regulatory submissions

HPLC/LC-MS

CMC analytical development

IND/CTA submissions

Leadership

Formation

Ph.D. in chemistry/analytical chemistry/organic chemistry

M.S. in chemistry/analytical chemistry/organic chemistry

B.S. in chemistry/analytical chemistry/organic chemistry

Description du poste

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 around the world 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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 the Advisor / Senior Advisor of Analytical Chemistry for linker payload of Antibody-Drug Conjugates, 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:

• Lead analytical efforts focused on development and commercialization of the linker payload intermediate required for antibody-drug conjugates, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Lead external and/or lead internal analytical method development and qualification of ADC linker-payload intermediate and RSM; establish specifications, characterize impurities and degradation pathways, support purge/fate studies, establish reference standard and stability studies
• Collaborate within project teams to deliver robust control strategies for linker payload intermediates and process impurities. Demonstrates a depth of knowledge in concepts relevant to the linker or payload, monoclonal antibody, drug substance, and drug product commercialization, including developing analytical methods, justifying specifications, authoring regulatory submissions and addressing questions from global regulatory agencies.
• Drive the implementation of technical solutions and analytical strategies to enable linker payload intermediate and/or conjugated drug substance/drug product process design.
• Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
• Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and fit-for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas; be able to use these techniques to bring value across the antibody-drug conjugate portfolio.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• Responsible for introduction of new methodologies for optimization of antibody-drug conjugate development and manufacturing.
• Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate closely with organizations across Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thoughts, backgrounds, and experiences to deliver innovative solutions.
• Possess strong communication (oral, written), organizational, and leadership skills.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly portfolio.

Basic Qualifications:

• Ph.D. in chemistry, analytical chemistry, or organic chemistry with 0-5+ years of experience in the pharmaceutical industry; or
• M.S. in chemistry, analytical chemistry, or organic chemistry with 6+ years of experience in the pharmaceutical industry; or
• B.S. in chemistry, analytical chemistry, or organic chemistry with 12+ years of experience in the pharmaceutical industry.
• Proven experience in CMC analytical development for linker-payloads/small molecule therapeutics or synthetic molecule.
• Strong expertise in analytical techniques such as HPLC, GC, IC, LC/MS, impurity profiling/structure elucidation, and method 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 to enable innovation which creates business value.
• Experience with analytical method development, control strategy implementation, and/or regulatory submissions related to linker-payloads or small molecule therapeutics.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience with management of a technical project.
• Demonstrated leadership capabilities especially in a team environment.
• Demonstrated ability to drive and accept change.
• Demonstrated success in persuasion, influence, and negotiation.

Additional Information:

• Travel: 0 to 15%
• Potential exposure to chemicals, allergens, and loud noises

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 (JILN), 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.

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