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:
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
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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
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.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. URL blocked - click to apply