Senior Director, MS&T

Job Summary

The Manufacturing Science and Technology (MS&T) Director or Senior Director is responsible for establishing and directing the execution, resources, business processes and best practices for tech transfer, process validation, and support laboratory activities for the MS&T department at the Durham Patriot Park Manufacturing site. The Director or Senior Director will manage a multi-disciplinary team of Engineers and Scientists and will collaborate with Process Development, Quality, Supply Chain, Facilities, Engineering, and Manufacturing to ensure projects are executed efficiently and in a timely manner. The Director or Senior Director should demonstrate proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices.

Job Responsibilities

• Drive new commercial product introduction and process validation from Stage 2 PPQ through Stage 3 CPV Process Validation and Pre-Approval Inspection (PAI)
• Drive new clinical product introduction to ensure successful tech transfer through collaboration with Process Development
• Establish and maintain the procedures, business processes and tools/systems for tech transfer to ensure that the business
• Establish standards and industry best practices to ensure organizational efforts are scalable and sustainable across sites
• Develop plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain
• Facilitate activities of department resources to facilitate revenue growth and risk mitigation for manufacturing organization
• Recruit and retain talent within organization
• Represent the department during audits, client meetings and multi-disciplinary meetings with boards of health and upper management
• Lead multi-disciplinary projects and strategic oversight for robust manufacturing operations, facility designs, new technology implementation, production revenue growth, cost of goods optimization and streamlined practices
• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promotion and disciplinary effort. Identify opportunities and provide the means for employees to pursue career growth

Minimum Requirements

• BS in Science or Engineering with minimum of 18 years industry experience, Masters with 16 years industry experience or PhD with 14 years industry experience
• Demonstrated biologics expertise in upstream or downstream processing and operations
• Experience in collaborating with process development, quality, supply chain, engineering and manufacturing
• Demonstrated expertise in technical transfer, process validation, process engineering and optimization/scale up of biological processes
• Demonstrated knowledge of industry best practices, boards of health guidelines, cGMP compliance and engineering standards
• Experience with cGMP production operations
• Experience working in a cGMP manufacturing environment (plus)

KBI Biopharma, Inc.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.