Scientific Lead, CMC Bioconjugation ID-5595

January 3, 2025

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.

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

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Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary

The CMC Biologics team has an exciting opportunity for an innovative individual to join our organization and develop the growing oncology portfolio of antibody-drug conjugates. This role can be located in Boulder, CO or Remote.

The Scientific Lead, CMC Bioconjugation will collaborate on phase appropriate bioconjugation process development and manufacturing efforts including optimization, characterization, and validation of the bioconjugation process for oncology programs.

Responsibilities

Work in a team environment to drive and manage bioconjugation development and manufacturing activities primarily at third-party partners for assigned projects.
Partner with colleagues in discovery, process development and analytical to develop integrated clinical process and manufacturing solutions that achieve quality by design targets with robust control strategies.
Develop the clinical stage/scale bioconjugation strategy and prepare to and/or enable registration/commercial stage/scale.
Provide technical and scientific direction to third-party partners.
Create written development instructions and work with third-party partners to perform desired experiments incorporating Quality by Design (QbD).
Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
Collaborate on product characterization/comparability and lot release studies.
Write and review sections in regulatory submission documents (e.g., IND, IMPD, BLA).
Key member of the interdisciplinary CMC project teams.

Basic Requirements

BS degree required. Prefer candidates with a Master's and/or PhD.
Minimum of three (2) years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
Strong background in hands on bioconjugation activities at lab and/or larger scale.
Strong background and experience with novel conjugation chemistries, including but not limited to native cysteine/lysine conjugation, enzymatic, site-specific conjugation

Additional Preferences

Experience with antibody drug-conjugate (ADC) modalities is a plus.
Experience with manufacturing including strong scientific and technical experience within relevant manufacturing process technologies and unit operations.
Knowledge of structured methodologies for process design, scale-up/down models, process control strategies, and process validation.
Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions.
Experience writing and presenting clearly on CMC topics.
Demonstrable ability to work proactively, independently, and tenaciously.