Kelly Scientific is seeking a Upstream Manufacturing Manager for
a DIRECT HIRE opportunity in Durham, NC . The incumbent will
oversee upstream manufacturing floor operations to ensure ‘Right
the First time’ execution of early and late-phase Cell Culture
programs safeguarding work environments and enforcing cGMP
The upstream floor operations manager will oversee manufacturing
floor supervisors and will report to the head of the upstream
manufacturing department. The individual will be responsible for
managing the mid-term and long-term schedule planning and be the
primary point of contact for daily issue escalation.
The individual will ensure their teams maintain strict
accordance with production batch records, SOPs and Good
Manufacturing Practices. The individual will also be responsible
for ensuring MRP transactions, manufacturing record reviews,
maintenance activities, and compliance documents are completed
timely and thoroughly. The individual will ensure that
manufacturing records and materials are available for timely
execution of activities to meet production schedules.
This proven and qualified candidate will use their past
experiences, depth and knowledge of cell culture fundamentals in
media preparation, seed expansion, bioreactor operations and cell
culture harvest operations to teach, troubleshoot and continuously
improve the production operations of Upstream manufacturing. The
ideal candidate will be both technically sound as well as an
experienced team motivator and coach.
Demonstrated knowledge of media preparation, shake flask
operations, reactor setup and operation, aseptic technique, cell
culture media preparation, cell culture analytical tools and
general biotechnology auxiliary equipment (pumps, sterile tubing
welders and sealers, pH/Conductivity/osmolarity meters) is expected
as the manager will teach, promote and enforce precise and
The manager will use their leadership and technical expertise to
drive process improvement initiatives, monitor processes and
equipment and troubleshoot issues, trend and track metrics and
author, review and approve procedures, deviations, CAPAs, and
change controls as needed.
Plan, schedule, and support medium and long term production
tasks ensure schedule adherence.
Facilitate additional manufacturing activities and process
support with other manufacturing groups, MS&T and PD, QA,
Maintenance and Engineering, and AFS and Microbiology.
Ensure timely execution and review of batch documentation and
logbooks, initiation of deviations, and execution and completion of
ERP orders. Ensure timely corrections to batch documentation and
Supervise, coach, mentor and train team members to maintain
educated, qualified and motivated employees. Ensure staff maintain
a high level of compliance to procedures and quality
Drive process improvement initiatives, troubleshoot issues,
trend and track metrics and author, review and approve procedures,
deviations, CAPAs, and change controls as needed
Ensure equipment and manufacturing facilities remain in working
order by overseeing production technician maintenance, cleaning,
and ensuring timely submission of work orders for facility and
equipment maintenance and repair.
Bachelor’s degree in a related scientific or engineering
discipline and 8-12 years’ experience in related GMP manufacturing
4-6 years prior leadership/supervisory experience.
Demonstrated knowledge of cell culture or fermentation unit
operation is preferred. Experience in single-use platform
technology is preferred.
Excellent written and verbal communication skills are
Energetic, motivated and dynamic individual.
Must be organized and able to focus in a face-paced,
multi-tasked environment and maintain operational efficiency and
Apply Today for Immediate Consideration!
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier
scientific and clinical companies looking to hire talented people
just like you. Every day, we match science professionals with dream
jobs that fit their skills and interests—it’s the way we think job
searching should be. Nearly 100 percent of our science recruiters
have a professional background/education in science, so we know a
thing or two about the science market and how to get you
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising
job seekers on new ways of working to reach their full potential.
In fact, we’re a leading advocate for temporary/non-traditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a
diverse workforce and providing accommodations for people with
disabilities in all parts of the hiring process as required under
its Employment Accommodation Policy. Kelly will work with
applicants to meet accommodation needs that are made known to Kelly