Upstream Manufacturing Manager - Direct Hire

Company: Kelly
Location: Durham
Posted on: October 14, 2020

Job Description:

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 compliant operations.

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 compliant operations.

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.

JOB RESPONSIBILITIES

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 logbooks.

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 expectations.

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.

MINIMUM REQUIREMENTS

Bachelor’s degree in a related scientific or engineering discipline and 8-12 years’ experience in related GMP manufacturing operations

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 required.

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor

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 noticed.

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 in advance.

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Keywords: Kelly, Durham , Upstream Manufacturing Manager - Direct Hire, Other , Durham, North Carolina