MS&T Manager

Manufacturing, Science, and Technology Manager (MS&T Manager) – Lenoir, NC, DIRECT HIRE

Kelly Services is currently seeking an Biomanufacturing Production Manager for a Direct Hire opportunity with one of our top clients in Lenoir, NC.

The mission of the Manufacturing, Science, and Technology team is to continuously improve the compliance, efficiency, and strategic position of the Lenoir site in harmony with global initiatives by applying technical, quality, and scientific principles to innovatively meet patient needs.  The core functions of MS&T include product characterization and analysis, product/process development, technology transfers, scale-down/at-scale process troubleshooting, and root cause analysis.

This position requires the following requirements for employment and includes but is not limited to:

 

Job Requirements:

This position requires the following minimum education and experience level: 

  • BS in chemical engineering, biochemistry, chemistry or equivalent physical science
  • 8+ years of experience in pharmaceutical/biotechnology industry
  • 5+ years of supervisory experience in sterile drug product formulation/down-stream process development

 

Additional Job Responsibilities:

 

  • In collaboration with Manufacturing, Quality, Validations, and Regulatory, ensure the robustness of manufacturing processes so that all site products are validated and remain in constant state of control throughout the product lifecycle
  • Provide scientific and technical expertise in the development and validation of new manufacturing operations for API/upstream processing and downstream processing, including transitioning of research techniques into cGMP production methods, to meet quality and regulatory standards.
  • Develop strategies for scale-down/scale-up and characterization of manufacturing processes
  • Lead process development team and operations personnel in process optimization and validation activities for existing unit operations in upstream/downstream processing; including the development, review, and approval feasibility/DoE studies and reports, analytical data summaries and reports, SOPs, master batch records, validation protocols, project summary reports, change controls, and regulatory filings.
  • Effectively communicate scientific and technical concepts, project objectives and vision, and data analysis and conclusions across business units and global sites. 
  • Build and maintain relationships, and promote collaboration and cross-functional teamwork to achieve mutual goals.
  • Understand and apply the business side of science i.e. cost of acquisitions, return on investments, development of new processes and technologies; Prepare annual operational and capital budgets including staffing, equipment, reagents and supplies and costs associated with process development, manufacturing, and testing.
  • Understand and apply statistics, Design of Experiments (DoE), Quality by Design (QbD), Process Analytical Technologies (PAT) and lean Six Sigma tools
  • Maintain team training in process development, quality/industry standards, GMPs, GLPs, and six sigma methodologies

 

Apply Today!

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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