Lead, MSAT - Manufacturing Science & Technology

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.


This position is responsible for establishing and managing the execution, resources, business processes and tech transfer for either the upstream or downstream groups within the MS&T department at our Sarasota Manufacturing site. This role will manage a team of Engineers and Scientists that lead tech transfer projects and will collaborate with Process Development and Manufacturing to ensure projects are executed efficiently and in a timely manner.

Responsibilities

• Oversee new commercial product introduction from Process Development PPQ through Process Validation Activities
• Establish and maintain the procedures, business processes and tools/systems for tech transfer
• Oversee new clinical product introduction and guide efforts to ensure successful tech transfer through collaboration with Process Development
• Establish plans and strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality and supply chain
• Manage scheduling resources and lead staff meetings.
• 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 to improve manufacturing operations, adopt new technologies, increase production revenues, reduce cost of goods, streamline 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.
• Establishes and maintains the procedures, business processes and tools for downstream tech transfer.
• Leads multi-disciplinary cross-functional projects. 
• Manages and facilitates resources to ensure execution success. 
• Provides technical oversight to tech transfer programs and personnel.

Requirements

• MS or BS in Science or Engineering with minimum of 5-7 years industry experience.
• Must have demonstrated biologics expertise in upstream or downstream processing and operations.
• Expertise with technical transfer and scale up is required.
• Experience with GMP compliance.
• Solid understanding of Process Development and cGMP production operations.
• Proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices. 

EOE/DFW