Senior Principal Scientist, Analytical Chemistry - Synthetic Molecule Design and Development

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. Were 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 Principal Scientist, Analytical Chemistry, will join a diverse team of analytical chemists, organic chemists, pharmaceutical scientists, and engineers to deliver product and process insights for synthetic peptide and oligonucleotide programs. Engaging with scientists across Lillys R&D, quality, and manufacturing organizations, this individual will be tasked with developing and implementing robust analytical methods and control strategies to enable clinical trial material delivery and build process understanding.

Responsibilities:

• Collaborate with project teams to develop robust control strategies for drug substances and drug products, enable clinical programs, and author regulatory submissions.
• Drive analytical method development, justify specifications, design stability studies, establish starting material rationales, identify impurities, and coordinate the testing of drug substance /drug product quality characteristics.
• 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 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.
• Identify and implement innovative solutions to development challenges, monitor emerging trends in analytical chemistry, and maintain familiarity with applicable regulatory requirements.
• Demonstrate strong written and verbal communication skills to represent both the technical aspects and business-related implications of your work.

Basic Requirements :

• BS or MS in Analytical Chemistry, Biochemistry, Chemistry, or a related field.
• 7+ years experience in the pharmaceutical industry.
• Deep understanding of analytical method characterization and the associated performance attributes (e.g., linearity, precision, LOD/LOQ).
• Experience with chromatographic separations and a strong working knowledge of other techniques commonly used for the analysis of synthetic molecules (e.g., MS, NMR, FTIR, KF, ICP, DSC, TGA, XRPD).

Additional Preferences:

• Familiarity with chemical process development, rationales for establishing material specifications, designing stability studies, and analytical method validation, preferably for synthetic peptides and oligonucleotides.
• Experience authoring or contributing to 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%
• Location: On-site position Indianapolis, IN Lilly Technology Center-North (LTC-N)

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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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is

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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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