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Eli Lilly and Company · 6 hours ago

Advisor ADC Drug-Linker Synthetic Process Development

Indianapolis, IN

Full-time

Onsite

Mid, Senior Level

$126K/yr - $205K/yr

0+ years exp

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. The position focuses on small-molecule drug-linker synthetic chemistry within the Bioproduct Research and Development organization, requiring collaboration to develop processes for ADCs and support the commercialization of biologic therapeutics.

BiotechnologyHealth CareMedicalPharmaceutical

H1B Sponsor Likely

Responsibilities

Synthesize complex payloads and drug-linkers for preclinical tox studies, and collaborate across internal Lilly networks to implement and deliver material and information

Possess fluent knowledge in synthetic organic chemistry methods, technologies, and techniques and apply these skills to design and develop robust synthetic manufacturing processes for use in clinical manufacturing campaigns

Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies

Work closely with early phase Discovery and Toxicology groups to support new and emerging assets in the portfolio via synthetic material supply

Provide technical leadership in the scale-up and demonstration of new chemical processes in development scale equipment; collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing

Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives

Support generating data to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies

Engage the external chemistry community through presentations and publications

Collaborate with other Lilly chemists, analytical chemists, bioconjugation scientists, engineers, CMC project management, Lilly manufacturing partners, and regulatory scientists to develop and commercialize ADCs

Oversee phase appropriate development activities such as route selection, process definition, and process characterization

Partner with external development and manufacturing organizations to quickly deliver on development and commercialization needs (data and material)

Author technical reports and CMC related documents including sections in regulatory submission documents (e.g., IND, IMPD, BLA)

Help drive internal facilities growth to support highly-potent and/or cytotoxic material handling through assisting in laboratory design and planning

Qualification

Synthetic organic chemistryDrug-linker process developmentHigh-potent laboratory experienceAntibody-Drug Conjugates (ADCs)Process modelingChromatographic purificationRegulatory knowledgeExperimental designTechnical leadershipCollaboration skills

Required

Ph.D in synthetic organic chemistry or relevant scientific discipline with 0-2 years of industry experience in the field of synthetic organic chemistry OR MS degree with 5+ years of relevant synthetic chemistry experience in an industry setting