Kelly Scientific is seeking a Downstream Manufacturing Manager
for a DIRECT HIRE opportunity in Durham, NC . Within the role the
manager will oversee the Downstream Manufacturing floor operations
(Protein capture through Bulk Filtration) and related Specialist
support teams to manufacture GMP drug substance while driving a
safe and compliant production environment through structured
Ensures schedule adherence for tasks including but not limited
to manufacturing, qualification, and maintenance activities.
Actively participate as a role model in Lean culture and
continuous improvement programs with responsibility to translate
onto the manufacturing floor.
Staff selection, training, oversight, performance evaluations,
Ensures standard operating procedures are accurate for executing
unit operations, batch record review & MRP transactions are
completed accurately meeting disposition timelines, trend and track
departmental metrics, and non-conformances are initiated and closed
with right the first-time documentation.
Reviews technical documents, change controls, solution records
and batch records for accuracy, thoroughness and regulatory
Elevate critical and impactful events to Director/Sr.
Utilizes leadership and technical expertise to make real time
processing decisions, monitors processes and equipment.
Troubleshoot and perform initial assessment of events that have
the potential to impact area safety and product quality.
Assists area manager with the implementation of long and
short-range plans, policies, programs and objectives.
Identifies, recommends and implements changes to improve
productivity and reduce cost and waste.
This proven and qualified candidate will serve as a subject
matter expert (SME) as required during regulatory inspections for
deviations, change controls, and process documentation. Make
decisions as a SME on mammalian large scale production processes
especially for chromatography and tangential flow filtration.
Perform miscellaneous duties and projects as assigned and
Plan, schedule, and support long and short-range plans,
production tasks to 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.
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
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
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 Chemical / Biochemical / Biological
Engineering or related discipline with 10+ years of experience in a
GLP, GMP and/or ICH/GCP environment or equivalent experience
4+ years of experience leading a team, managing others directly
Mechanical ability/expertise coupled with a solid technical
background of purification processes and equipment, strong
knowledge of GMP practices preferred.
Experience in single-use platform technology is preferred.
Excellent organization, technical writing and communication
Energetic and motivated individual with the ability to
multi-task and meet aggressive deadlines for clinical 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