Scientist Primary Loop Technical Service / Manufacturing Sciences (Night Shift)
Company: Eli Lilly
Location: Fairland
Posted on: August 7, 2022
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 35,000 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. Company Overview: 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 39,000 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. #WeAreLilly Organization
Overview:The mission of Technical Services/Manufacturing Sciences
(TS/MS) is to provide scientific leadership and technical support
for manufacturing to make medicine today and tomorrow. The Primary
Loop Scientist provides frontline, technical support to to the
manufacturing operations through either product- and process-
focused ownership to achieve the reliable and compliant manufacture
of parenteral drug product per a detailed set of manufacturing
instructions and procedures. This role interacts daily with a wide
variety of people, including cross-functional team members,
Operations staff, other personnel, plant leadership and other Lilly
sites as needed. This Primary Loop position will provide the
technical support as described above during the night shift, in
addition to other responsibilities. Responsibilities:
- Understand the scientific principles required for manufacturing
parenteral drug products, including the interaction of the
chemistry, equipment, aseptic processes, and container closure
systems on inspection processes.
- Ensure that an accurate instruction set (tickets & procedures)
and Process Flow Documentation describe the process as performed
and the control strategy for the discrete manufacturing steps.
- Monitor the technical performance of manufacturing regularly
through observation, interactions in production areas, and review
of production and quality data to assure the process is in control
and capable.
- Provide technical input as part of a cross-functional team when
issues arise during manufacturing.
- Provide technical leadership to TS/MS and cross-functional
teams including troubleshooting, risk assessments, process
ownership and technical agenda/project management
- Prepare, review, approve, and provide technical support for
preparation of relevant technical documents, as required, such as:
change controls, regulatory submissions, deviation investigations,
validation protocols and summary reports, processing records,
manufacturing ticket inserts, procedures, PFDs, VMPs, APRs, QPPAs,
etc.
- Support or lead projects for improvement to the process,
training, procedures, and other controls to assure reliable supply,
improve process control, yield, purity, and/or productivity.
- Understand, justify and document the state of validation with
data that evaluate the capability of the manufacturing process to
meet its stated purpose.
- Understands, and performs all job responsibilities in
compliance with safety and regulatory expectations as well as
cGMP.
- Engage in internal and external networking with various
functional teams to ensure proper knowledge and data
transfers.Minimum Requirements:
- Bachelor's or other 4 year degree in a scientific discipline of
Biochemistry, Chemistry, Biophysical Chemistry, Bioanalytical
Chemistry, Microbiology, Biology, Analytical Chemistry, Chemical
Engineering or related Engineering discipline
- MUST be able to work on night shiftAdditional Preferences:
- Technical/Scientific knowledge
- Strong written and oral communication skills
- Clear understanding of cGMPs within a pharmaceutical
manufacturing environment
- Teamwork, ability to influence teams, and interpersonal
skills
- Computer skills
- Decision making
- Multi-tasking
- Problem solvingAdditional Information:
- This role is primarily a weekday night shift position, with
on-call hours support expected, as needed.This job specification is
intended to provide a general overview of the job requirements at
the time it was prepared. The job requirements of any position may
change over time and may include additional responsibilities not
specifically described in the job specification. Eli Lilly and
Company, Lilly USA, LLC and our wholly owned subsidiaries
(collectively "Lilly") are committed to help individuals with
disabilities to participate in the workforce and ensure equal
opportunity to compete for jobs. If you require an accommodation to
submit a resume for positions at Lilly, please email Lilly Human
Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for
further assistance. Please note This email address is intended for
use only to request an accommodation as part of the application
process. 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.
As a condition of employment with Eli Lilly and Company and its
subsidiaries in the United States and Puerto Rico, you must be
fully COVID-19 vaccinated and provide proof of vaccination
satisfactory to the company (subject to applicable law).
#WeAreLillyRequired
Keywords: Eli Lilly, Indianapolis , Scientist Primary Loop Technical Service / Manufacturing Sciences (Night Shift), IT / Software / Systems , Fairland, Indiana
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