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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.

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 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.

Position Summary:

The Senior Research Advisor, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists 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 technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development.

Responsibilities:

+ Develop analytical methods, justify specifications, design stability studies, establish starting material rationales, identify impurities, and test drug product performance characteristics.

+ Collaborate with project teams to develop robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions), enable clinical programs, and author regulatory submissions.

+ Support internal process development efforts through hands-on laboratory research in a fast-paced development environment. This includes experimental design, sample analysis, instrument troubleshooting, and data interpretation.

+ 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 external organizations and Lilly manufacturing sites.

+ Plan and handle 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.

+ Identify and implement innovative solutions to development challenges, monitor emerging trends in analytical chemistry, and maintain familiarity with applicable regulatory requirements.

**Basic Requirements** :

+ Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, or a closely related scientific discipline.

+ 3+ years of industry experience in analytical development within the pharmaceutical or biotechnology sector, including experience supporting clinical-stage programs.

+ Deep fundamental understanding of and experience with multiple forms of chromatography and mass spectrometry, as well as a strong working knowledge of other techniques commonly used for the analysis of synthetic molecules (e.g., NMR, FTIR, KF, ICP, DSC, TGA, XRPD)

+ Demonstrated experience in method development, validation, and transfer for oligonucleotides, peptides, or small molecules.

Additional Preferences:

+ Experience authoring regulatory documentation (e.g., IND/CTAs, NDA/MAAs) and overseeing CMO/CRO activities

+ Demonstration of scientific leadership and the ability to influence others

+ Ability to prioritize multiple responsibilities, influence others, and thrive in ambiguity

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

$121,500 - $198,000

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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