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.

The scope of this role includes:

• 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
• Drive standards and industry best practices to ensure organizational efforts are scalable and sustainable across sites
• Establish plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain
• Drive 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.

JOB RESPONSIBILITIES

The candidate must apply sound judgment and effective decision making to drive the strategic objectives of the department and influence the broader business as a whole. In addition, the candidate is required to apply sound technical and management principles in order to drive tech transfer, process validation, process engineering and execution of support laboratory efforts and facilitate project execution and department performance within defined timelines. The ability to manage multiple projects and resources is required.

The candidate should have the ability to drive direction and have excellent communication skills in order to influence company objectives.

• Leads multi-disciplinary cross-functional projects
• Provides technical guidance to tech transfer, process validation, process engineering and laboratory efforts
• Oversees and maintains the procedures, business processes and tools for downstream tech transfer.
• Represents department in various technical and projects team meetings with client, board of health and upper management.

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.
• Must have demonstrated biologics expertise in upstream or downstream processing and operations
• Must have 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 is required
• Demonstrated knowledge of industry best practices, boards of health guidelines, cGMP compliance and engineering standards is required
• Experience with cGMP production operations is required
• Experience working in a cGMP manufacturing environment is a plus