Sr. Scientist TSMS API EM
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: June 24, 2025
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Job Description:
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:
Join the energetic and growing Active Pharmaceutical Ingredient -
External Manufacturing Organization (API-EM) that delivers a
diverse portfolio of medicines essential to our patients around the
world. The API EM TS/MS Sr. Scientist will provide technical and
scientific expertise within a dynamic external manufacturing
environment. The Sr. Scientist is responsible for providing
technical support to achieve the reliable and compliant manufacture
of API drug substance at external contract manufacturing groups to
predetermined global quality standards. This person interacts daily
with a wide variety of people, primarily external partners team
members and site management. The candidate will be responsible for
process monitoring, response to issues, and improvements where
necessary. A strong understanding of manufacturing principles and
Lilly systems is required to ensure those same standards are
applied to the external contract manufacturers. This is a Large
Molecule (mAb and ADC) position. The position requires knowledge of
cGMPs, applicable global regulatory manufacturing guidance, and the
corporate/industry standards. The position requires working
cross-functionally within the site and other functions to deliver
on technical objectives. Responsibilities: Provide technical
oversight for monoclonal antibody and antibody drug conjugate
manufacturing processes. Leads resolution of technical issues
including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and
external relationships. Build and maintain relationships with
development and central technical organizations. Ensure proper
characterization of processes and products and ensure effective
documentation of the process description, measures, acceptable
ranges, and specifications (and the justification of these
measures, acceptable ranges, and specifications). Ensure that
processes are compliant, capable, in control, and maintained in a
validated or qualified state. Understand, justify and document the
state of validation with data that evaluate the capability of the
manufacturing process to meet its stated purpose. Influence and
implement the network technical agenda and drive continuous
improvement. Maintaining mAb and ADC processes in a state of
compliance with US and global regulations Understanding the
scientific principles required for manufacturing intermediates and
drug substances, including the interaction of chemistry and
equipment. Operate with ‘Team Lilly’ in mind - including coaching
and mentoring of peers and other scientists. Basic Requirements:
Bachelors in scientific disciplines of Biotech, Chemistry,
Biochemistry, Biology, Pharmacy, or Engineering
(Biotech/Biochemistry strongly preferred) 3 years of demonstrated
hands on working experience and proficiency with pharmaceutical
manufacturing and working knowledge of regulatory expectations.
Additional Preferences: Knowledge and experience with Regulatory
requirements Knowledge of data management practices across
manufacturing Enthusiasm for changes, team spirit and flexibility
Ability to influence and communicate to diverse groups on business,
or technical issues within the site and function Proficiency in
delivering complex tasks and/or tasks that are cross-functional
Demonstrated Project Management skills and ability to coordinate
complex projects Additional Information: Some travel ( Some
off-shift work (night/weekend) may be required to support 24/7
operations. 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 proud to be an
EEO Employer and does not discriminate on the basis of age, race,
color, religion, gender identity, sex, gender expression, sexual
orientation, genetic information, ancestry, 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 are open to all employees.
Our current groups include: Africa, Middle East, Central Asia
Network, Black Employees at Lilly, Chinese Culture Network,
Japanese International Leadership Network (JILN), Lilly India
Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ
Allies), Veterans Leadership Network (VLN), Women’s Initiative for
Leading at Lilly (WILL), enAble (for people with disabilities).
Learn more about all of our groups. Actual compensation will depend
on a candidate’s education, experience, skills, and geographic
location. The anticipated wage for this position is $64,500 -
$167,200 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. WeAreLilly
Keywords: Eli Lilly and Company, Bloomington , Sr. Scientist TSMS API EM, Science, Research & Development , Indianapolis, Indiana
