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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$133,500 - $195,800

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.

Scientific Lead, CMC Bioconjugation ID-5595

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

DISCLAIMER

Other Jobs You May Be Interested In

Scientific Lead, CMC Bioconjugation ID-5595

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

5. HOW DO YOU PROCESS INFORMATION?

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

8. HOW TO PRIORITIZE WORK?

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

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