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

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.

Additional Information

Physical Demands/Travel:

The physical demands of this job are consistent with an office environment with < 10% travel.  

 The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office setting.  

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

FOR HR USE ONLY

Lilly currently anticipates that the base salary for this position could range from between $121,500 to $178,200 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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