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.

Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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, and other emerging therapeutic modalities. By cultivating 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.

Our team is seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences to develop robust control strategies, enable clinical trials, regulatory submissions, and new product commercialization for our antibody-drug conjugate (ADC) portfolio. This role offers the opportunity to lead analytical efforts within a multidisciplinary team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical product development. The scope of this role will involve developing the methodology for characterizing the linker-payload components of ADCs, establishing testing plans and specifications for these components, and collaborating with project teams to develop successful, reproducible processes for antibody conjugation.

Responsibilities:

• Drive the implementation of technical solutions and analytical strategies to enable synthetic chemistry and process engineering associated with ADC development and manufacture.
• Collaborate within project teams to deliver robust control strategies for drug substances and drug products.
• Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and characterized. 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); be able to use these techniques to bring value across the portfolio.
• Possess experience with drug substance and drug product Common Technology Document (CTD) authoring, NDA submission, Pre-approval inspection (PAI) readiness of manufacturing sites, and Country-specific Response to Questions (Rt Q) approaches leading to successful approvals.
• Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
• 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 Development and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thought, background, and experience 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 synthetic portfolio.

Requirements:

• Possess prior experience leading analytical efforts focused on pharmaceutical development and commercialization of ADCs (with specific focus on the payload-linker components preferred) or small molecule therapeutics, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
• Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with 2+ years of experience in the pharmaceutical industry or alternatively a B.S. in chemistry with 15+ years (or M.S. in chemistry with 10+ years) of experience in the pharmaceutical industry

Additional Skills/Preferences:

• Strong fundamental understanding of and practical experience with analytical separation techniques (e.g., HPLC, GC, IC), method validation, and impurity elucidation
• 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
• Strong technical skills to enable innovation which creates business value
• 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
• Good interpersonal skills and a sustained tendency for collaboration
• Ability to prioritize multiple activities and manage ambiguity
• Ability to influence others to promote a positive work environment
• Demonstrated technical proficiency and ability to create ideas for future work plans

Additional Information:

• Travel: 0 to 10%
• Position Local: 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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