Operations Manager - Parenteral Manufacturing
Posted on: November 19, 2021
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.
At Lilly, we serve an extraordinary purpose. We make a difference
for people around the global 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 Brand Description:
Lilly unites caring with discovery to create medicines that make
life better for people around the world.- Lilly is a fortune 500
company that has been in operation for over 140 years.- We make
medicine with safety first and quality always while living our
company values of Integrity, Excellence, and Respect for
Lilly is designing and building a new state of the art Parenteral,
Device Assembly, and Packaging Facility located at the Research
Triangle Park (RTP) in North Carolina.- This is an exciting
opportunity to help build and operate a state-of-the-art
manufacturing site from the ground up.
The Operations Manager for parenteral operations (Visual
Inspection) is responsible for the staffing, training, and
leadership of the operations group supporting asset delivery,
process development, operational readiness, start up, and
validation of the parenteral operations areas.- After starting up,
the operations manager will be responsible for overseeing the
day-to-day activities of their operational area as well as planning
for the 3 - 6-month horizon.- They are expected to lead by example
and provide coaching to others in the areas of safety, quality,
operational execution, sterility assurance, and continuous
improvement. The Manager is also responsible for leading their
respective process team per Lilly's Manufacturing Standards for
- Support Site Leadership to build a diverse and capable site
organization by delivering area operational procedures, quality
processes and controls for the Parenteral manufacturing area.
- Managers are responsible for a work force of approximately 40 -
70 individuals on various shifts, with multiple shift supervisors
reporting directly to them.
- Ensure consistency of operations across shifts through active
engagement on the shop floor and through Gemba walks and Practice
vs. Procedure evaluations.
- Provide leadership and develop objectives to deliver Business
Plan Goals as it relates to production volumes, financial, safety,
quality, stewardship, and people.
- Maintain metrics to measure performance against business
objectives and make necessary changes to improve performance.
- Participates in the development and implementation of
strategies associated with the area sponsoring or supporting the
following initiatives: Continuous Improvement, Root Cause Analysis
(RCA), Failure Modes Effect Analysis (FMEA), Operational Standards
for Supply Chain Excellence (OSSCE).
- Lead/conduct area deviation and corrective action discussions
with a cross-functional team from Engineering, Maintenance,
Technical Services / Manufacturing Sciences (TS/MS), Quality, and
Health, Safety, and Environmental (HSE) functional groups
- The Manager functions as a primary contact for other areas such
as Production Planning, HR, Quality Assurance, Engineering and
- Present operations investigations and procedures to Regulatory
Agencies and act as a Subject Matter Expert (SME) for audit tours
- Managers are responsible for leading the Operations Process
Team, a cross functional group charged with making medicine,
continuous improvement, and site support.
- Understand and influence the manufacturing control strategy for
- Represent their Operations Process Team on the Plant Flow
- At least 7 years working in the pharmaceutical industry.
- Previous management or leadership experience including leading
or working effectively with a cross functional group.
- Solid understanding of basic requirements of regulatory
agencies such as the FDA, EMEA, DEKRA, and OSHA.
- Excellent interpersonal, written and oral communication
- Strong technical aptitude and ability to train and mentor
- Previous experience in operations
- Previous experience in automated, semi-automated inspection,
and manual inspection
- Previous experience with highly automated equipment
- Previous experience with creation of Standard Operating
Procedures, Work Instructions etc.
- Previous experience with equipment design documentation
- Previous facility or area start up experience.
- Previous equipment qualification and process validation
- Previous experience with Manufacturing Execution Systems and
electronic batch release.
- Previous experience with Automated Storage and Retrieval System
(ASRS) Warehouses or AGVs.
- Previous experience in statistical process control and Six
- Previous experience with documentation, deviation and change
management systems (e.g., Trackwise. Veeva QualityDocs)
- Bachelor's degree in a science, engineering, or pharmaceutical
related field of study.
- The position is for the Lilly Research Triangle Park site and
during the project phase will allow for a flexible working
environment with the ability to periodically work remotely based on
the project phase and site activities.
- Position may require a short duration assignment of 1-2 months
in Indianapolis to establish specific device knowledge and
establish global contacts.
- Ability to work 8-hour days - Monday through Friday
- Ability to work overtime as required
- Ability to travel up to 20% during Asset Delivery and
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
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. - If you would like to request an
accommodation for medical or religious reasons, you may do so at
Keywords: Lilly, Durham , Operations Manager - Parenteral Manufacturing, Executive , Durham, North Carolina
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