Director - Analytical Chemistry

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Job summary

Lilly, headquartered in Indianapolis, IN, seeks an experienced analytical sciences leader to drive the analytical strategy for drug substance and drug product development across multiple modalities. You will lead a small technical team, mentor scientists, and partner with chemists, formulation scientists, and engineers to enable clinical trials and regulatory submissions.

This hands-on leadership role requires deep technical expertise, strong people leadership, and the ability to accelerate

Qualifications

• Ph.D. in analytical chemistry or bioanalytical chemistry with >8 years in pharmaceutical industry.
• Project/technical leadership in pharmaceutical product development with focus on small molecules, peptides, oligonucleotides, and ADC payload-linkers.
• Familiarity with regulatory requirements and emerging industry trends.

Responsibilities

• Lead analytical efforts within a multidisciplinary project team and manage 2–4 direct reports.
• Develop analytical methods and strategies for drug substance and drug product development.
• Provide technical guidance and spearhead technology transfer to CRO/CMO and Lilly sites.

Skills

Analytical leadership

Regulatory knowledge

Analytical chemistry expertise

People management

Education

Ph.D. in analytical chemistry or bioanalytical chemistry

Job description

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 Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (ADCs) and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.

About This Opportunity

SMDD is seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This is a hands-on technical leadership role where you will lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers, while directly managing a small technical team of analytical scientists. The position offers access to world-class capabilities for pharmaceutical development and requires a balance of deep technical expertise with people leadership.

This is a unique opportunity to shape the future of pharmaceutical development across multiple cutting-edge modalities while building a distinguished career at a company where your analytical expertise will directly accelerate life-changing therapies to patients worldwide.

Position Responsibilities

This is a technical leadership position with direct responsibility for executing analytical work alongside managing a small team of analytical scientists. Directors in this role will be responsible for hands-on technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes, while mentoring and developing their direct reports. Top candidates for this position will be expected to:

• Exhibit a depth of knowledge in concepts relevant to drug substance or drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, establishing starting material rationales for synthetic processes, identifying impurities, and testing drug product performance characteristics (e.g., dissolution/disintegration).
• Drive hands-on implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
• Collaborate within project teams to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
• Have experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
• 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 (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
• Directly manage, mentor, and develop a small team of analytical scientists (typically 2-4 direct reports). Ensure continued technical and professional growth of team members, encourage efforts towards excellence and knowledge sharing, and provide day-to-day technical guidance on analytical projects.
• 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.
• Excel in communication, leadership, and collaboration—embracing diverse perspectives to drive innovative solutions across multidisciplinary teams.
• Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

Basic Qualifications

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with >8 years of experience in the pharmaceutical industry after earning a degree.
• Project/technical leadership experience within an innovator organization focused on pharmaceutical product development and commercialization with specific focus on small molecules, synthetic peptides, oligonucleotides, and/or the payload-linker elements of ADCs, ARCs, etc.
• Demonstrated familiarity with applicable regulatory requirements and emerging trends in the industry.

Additional Skills/Preferences

• Strong technical skills to enable innovation which creates business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Demonstrated ability to drive and accept change.
• Proven ability to influence, persuade, and negotiate effectively to drive alignment and promote a positive, collaborative work environment.
• Ability to prioritize multiple activities and manage ambiguity.
• Demonstrated technical proficiency and ability to create ideas for future work plans.

Additional Information

• Travel: 0 to 10%
• Position Location: On-site, 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 (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 $148,500 - $257,400

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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