Senior Director Antibody-Drug Conjugate Drug Linker 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.

Organization Overview:

Bioproduct Research and Development (BRD) is the large-molecule process development organization within Lilly.  BRD is responsible for material and data generation to support clinical trials and commercialization of biologic therapeutics such as mAbs and bioconjugates. Our team will collaborate closely with the bioconjugation team to accelerate the development of lifesaving new medicines for our patients. Our antibody-drug conjugate (ADC) team seeks to perform innovative and cutting-edge research to deliver complex drug-linkers and bioconjugation methods to support clinical trials and commercialization.  We collaborate with our Synthetic Molecule Design and Development (SMDD) and biologics development colleagues to develop this exciting class of new drugs and seek fundamental learning and platform approaches to their development.

Responsibilities:

Our team is tasked with growing the chemistry infrastructure to conduct the 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 and regulatory submission strategies, often with compressed timelines.

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

• Manage multiple projects and/or material deliveries simultaneously.

• 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).

• Assist with data collection, assembly, and authorship of regulatory submissions to support clinical trials and product commercialization.

• Bridge the gap between the small and large molecule worlds to understand the needs of the project and ensure that process development is thorough and complete.

• When appropriate, mentor, train and supervise junior team members in this role.

• Help drive internal facilities growth to support highly-potent and/or cytotoxic material handling.

• Bring new and useful concepts, methods, and ideas for how research can be improved to make our group better.

• Engage externally through presentations and publications. Identify and develop chemistry innovations from the outside to complement existing capabilities and incorporate these innovations across the portfolio.

• Help drive and develop the commercial manufacturing strategy and collaborate with manufacturing partners to deliver robust chemical processes that are suitable for commercial-scale manufacturing.

Basic Requirements:

• PhD in synthetic organic chemistry with 7+ years of relevant industrial experience in the development of small molecules, especially of drug-linkers for ADCs or other bioconjugates.

Additional Skills/Preferences:

• Working knowledge of bioconjugation principles and development/purification methods.

• Basic understanding of cGMP principles and previous oversight of cGMP processes.

• Demonstrated control strategy development capabilities (e.g. nitrosamine, conjugatable impurities).

• Demonstrated registration stability, process validation, or post-approval process development leadership.

• Track record of personnel mentorship and development to grow the next generation of scientists.

• Ability to prioritize multiple activities and thrive in a setting that requires quick movement between scientific challenges and comfort with ambiguity.

• An active scientific curiosity and interest for com