Advisor ADC Drug-Linker Synthetic Process 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. We're looking for people who are determined to make life better for people around the world.

Organizational Overview:

The Bioproduct Research and Development (BR&D) organization strives to deliver innovative medicines to patients through the development and commercialization of monoclonal antibodies, novel therapeutic proteins, peptides, bioconjugates, cell therapies, gene therapies, and other genetic medicines etc. This organization is a multidisciplinary group that works collaboratively with our discovery, manufacturing and quality, business units.

Position Summary:

The current position focuses on small-molecule drug-linker synthetic chemistry. The current opportunity is within the Bioproduct Research and Development (BR&D) organization, which is a multidisciplinary organization focused on the development and commercialization of biologic therapeutics such as monoclonal antibodies and bioconjugates. Due to a strategic commitment to the growth of novel modalities such as Antibody-Drug Conjugates (ADCs) and an exciting pipeline of investigational medicines within the Lilly portfolio, we are seeking outstanding candidates to work at this exciting small molecule - biologics interface.

The successful candidate will interface closely with the biologics development in  &D and with the Synthetic Molecule Design and Development organization (SMDD) at Lilly.

Position Responsibilities:

To meet the needs of Lilly's expanding and diverse portfolio of ADCs, our team is tasked with growing the chemistry infrastructure to conduct the synthesis and process development of highly-potent and/or cytotoxic ADC drug-linkers. We will utilize a combination of in-house and external development, while building the capabilities to develop and transfer processes to internal and external manufacturing partners. A successful applicant should bring a skillset and knowledge to help grow our team's capabilities, research facilities, and infrastructure.

Lilly has an expanding and diverse portfolio of ADCs that require thorough drug-linker process development.

* 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.

Basic Requirements:

* 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.

Additional Skills/Preferences :

* Experience working in a high-potent laboratory environment, with experience handling…