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15 days old

Manufacturing Support Manager - Cell Culture/BioPharmaceuticals - Direct Hire

Kelly Services
Durham, NC 27722
Kelly Scientific is seeking a **Manufacturing Support Manager** for a **DIRECT HIRE** opportunity in **Durham, NC** . The manufacturing support manager will oversee the management of the manufacturing support activities in support of the startup and production at a new commercial GMP biopharmaceutical manufacturing facility. The individual will lead the manufacturing support team with the aim of achieving superior quality, safety, productivity and cost objectives. The individual will lead the manufacturing readiness activities during the construction, commissioning, and qualification of the facility. The manager will oversee all manufacturing support staff, with manufacturing supervisors and specialists as direct reports and will report to the Director of Manufacturing.




+ This proven and qualified candidate will use their past experiences, depth and knowledge of manufacturing support equipment such as parts washers, autoclaves, media and buffer preparation equipment and operations to teach, troubleshoot and continuously improve the production operations. Additionally, the individual will oversee the staff responsible for cleaning the manufacturing facility. The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

+ 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.

+ The individual will be responsible for managing the mid-term and long-term schedule planning for their department and be the primary point of contact for daily issue escalation.

+ The manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, 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 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.

+ Ensure timely execution and review of procedures, batch documentation, logbooks, deviations, CAPAs, change controls, and completion of ERP orders. Drive requirements to ensure rapid batch disposition.

+ Hire, train and develop a highly motivated and engaged high performing team. 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. Serve as a SME during internal and external audits and inspections.

+ Ensure equipment and manufacturing facilities remain in superior working order by demonstrating a clear sense of ownership, accountability, and pride by performing routine walkthroughs, setting high standards for their staff, and ensuring facility and equipment work orders are executed timely and effectively.



**MINIMUM REQUIREMENTS**




+ B.S. degree in a life sciences or engineering discipline and 9+ years experience in related GMP manufacturing operations or a Masters degree and 7+ years experience in related GMP manufacturing operations. Level commiserate with education and experience.

+ 3+ years prior leadership/supervisory experience.

+ Demonstrated knowledge of cell culture or fermentation unit operations are 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.
Posted: 2020-10-14 Expires: 2020-11-23

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Manufacturing Support Manager - Cell Culture/BioPharmaceuticals - Direct Hire

Kelly Services
Durham, NC 27722

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