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Downstream Manufacturing Manager - Direct Hire

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

Job Description:

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 on-floor presence.

Responsibilities include:

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, and development.

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 compliance.

Elevate critical and impactful events to Director/Sr. Management.

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 required.


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 expectations.

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.

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 considered.

4+ years of experience leading a team, managing others directly or indirectly.

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 skills.

Energetic and motivated individual with the ability to multi-task and meet aggressive deadlines for clinical and commercial production.

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.


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

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