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Director, R&D, Technology Transfer and Process Validation

Director, R&D, Technology Transfer and Process Validation

AOA is seeking a driven and experienced Head of Technology Transfer and Process Validation to support technology transfers, process validation, and manufacturing scale up. The Head of Technology Transfer and Process Validation will manage contract labs, developers and Manufacturing facilities and will be responsible for project management and technical oversight of transfers spanning the product lifecycle from Research to Commercial Manufacturing. The successful candidate will report to the CEO and will be part of the Leadership Team.                                                                                

Responsibilities:

  • Lead technology transfers for ELISA assays and monoclonal antibodies spanning Research, Process Development, Clinical, and Commercial Manufacturing                         
  • Establish strategic goals and objectives and maintain full strategic responsibility for the department                      
  • Own the product pipeline, accountable for product performance and delivery                         
  • Manage stakeholders across functions and levels within an organization; maintain communication across manufacturing network to ensure coordination and alignment                         
  • Oversee product improvements for performance, robustness, and manufacturability                         
  • Develop phase-appropriate technology transfer business process including technical documentation, gap assessments, risk assessments, verification/validation protocols and reports that meet FDA requirements for medical devices         
  • Design compliant process validation and comparability strategies to support regulatory filings 
  • Remain current on regulatory guidance on process validation and comparability
  • Support regulatory filings and facility startup as needed 
  • Manage a network of contract labs, developers and manufacturer
  • Create an environment of strong team spirit across all involved parties, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term                
  • Able to develop talent and create a working culture that is transparent and values-driven to accelerate the personal growth of employees
   
Requirements:
  • A Ph.D.-level degree in Biology, Biochemistry or Chemistry or comparable 
  • At least 5 years of experience in assay development (preferably in a GMP environment and with interactions with health authorities) 
  • Agile mindset, demonstrated ability to perform in the fast-moving world of a startup                         
  • Profound knowledge of ELISA Assay Technology and development in a regulated environment, including history of successful IVD product transfers 
  • Deep knowledge of Antibody Development 
  • Outstanding communication and presentation skills
Application

Please submit your resume to info@aoadx.com to apply. 
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