Sr. Principal Scientist – CT Parenteral Ops
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 16, 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. For 140 years, Lilly has
manufactured medicines that improve people’s lives around the
world. We produce our medicines using some of the most
sophisticated manufacturing technologies and rigorous quality
standards. Lilly Manufacturing strives for excellence in its
process, standards, procedures and behaviors to develop medicines
with safety first and quality always. This position is within the
Operations (OPS) team of the manufacturing organization. The
Scientist will provide technical oversight and ownership for
assigned processes which could include, dispensing and formulation,
filling, freeze drying, inspection and/or final packing into
shippable containers. The Scientist will also represent, and be the
primary owner, of new product technology transfers to B358 CT
operations while supporting day-to-day manufacturing operations.
The scientist will effectively collaborate with both internal and
external partners to achieve desired results. Key
Objectives/Deliverables: Knowledgeable on how to apply GMPs in a
clinical trial environment Capability to write, train, review, and
follow procedures applicable to the CT business Responsible for
issuance of pre-executed B358 CT manufacturing batch records and
performing post-execution technical review Utilize change
management system to create, approve, execute, close changes and
associated action items relevant the CT manufacturing process
Ownership of ancillary support processes (Filter Integrity Testing,
etc) Author and review GMP manufacturing related investigations and
complaint investigations Author, review, and execute nonroutine
technical studies to support manufacturing Ownership of Process
Risk Assessments Maintain ownership and emphasis on quality,
ensuring quality in all daily activities Responsible for
maintaining the B358 approved GMP consumables list and performing
activities for adding new consumables Responsible for performing
SME review of vendor changes Support process engineers with
manufacturing technical oversight Participate in new equipment
PQ/startup activities through Reviews, Approvals, Execution and/or
consultation on activities as needed Basic Requirements: 5 years
experience in Formulation Development, CT or Commercial
manufacturing. Exceptional organizational skills with attention to
detail Strong problem-solving skills with the ability to identify
key issues in manufacturing process and lead a team to the
appropriate solution(s) for complex problems Excellent verbal and
written communications skills with the ability to interact well in
a team environment and across multiple levels of an organization
Must be able to work in an environment with a lot of autonomy
Additional Preferences: Experience with freeze-dry operations.
Experience with single-use formulation bags and filling assemblies.
Familiarity with Trackwise1000 and SAP. Education Requirements: BS
in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical
Engineering or related field. Additional Information/Requirements:
Monday through Friday Day Shift Some work outside of core hours may
be required to enable the delivery of the portfolio Some domestic
and/or international travel required 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
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