BioSpace
Senior Principal Scientist, Analytical Chemistry - Synthetic Molecule Design and
BioSpace, Indianapolis, Indiana, us, 46262
Senior Principal Scientist, Analytical Chemistry – Synthetic Molecule Design and Development
Location: On‑site, Indianapolis, IN – Lilly Technology Center‑North (LTC‑N). Travel: 0–10%.
At Lilly, we unite caring with discovery to make life better for people around the world. Our 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.
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 Lilly’s 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 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)
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.
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 – $162,800. 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, medical, dental, vision, and prescription drug benefits, flexible benefits, life insurance and death benefits, certain time off and leave of absence benefits, and well‑being benefits.
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Research, Analyst, and Information Technology.
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At Lilly, we unite caring with discovery to make life better for people around the world. Our 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.
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 Lilly’s 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 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)
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.
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 – $162,800. 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, medical, dental, vision, and prescription drug benefits, flexible benefits, life insurance and death benefits, certain time off and leave of absence benefits, and well‑being benefits.
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Research, Analyst, and Information Technology.
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