Scientist, Process Development

Location
Sarasota, FL
Posted
May 30, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

 
Process Development Scientist

Key responsibilities include:
  • Highly involved in the scale-up and technology transfer of manufacturing processes for the production of commercial-scale plasmid production.
  • Responsible for authoring and reviewing technical reports, protocols, technology transfer documents, and CMC sections in regulatory filings.
  • Lead and participate in on-going technology development efforts, including the development of cell culture media, improving the efficiency and productivity of our platform processes, and the application of cell culture processes.
  • Participate in strategic planning for the direction of the the CMC organization by making presentations to senior management, providing periodic progress updates on projects and proposals for new technology development initiatives and advanced data analytics.
  • Manage and provide development opportunities for of a small team of junior scientists.
  • Represent the department on project teams.
  • Lead and participate in ongoing platform development initiatives including the development of perfusion/continuous upstream processes and technology development efforts.
Qualifications:
  • PhD or equivalent experience in Chemical/Biochemical Engineering or related Biological Science with 4+ years of industrial experience in the Biotech industry.
  • Experience in developing cell culture processes for production with exposure to cGMP requirements.
  • Experience in technology transfer to manufacturing.
  • Hands-on experience with process scale-up/process characterization.
  • Experience in authoring CMC sections for regulatory filings.
  • 4+ years of supervisory experience leading technical teams.
  • Familiarity with current QC approaches and Control Strategy Development
  • Very good understanding of small-scale model qualification and challenges faced during scale-up
  • Good communication skills and ability to work in teams
  • Detailed knowledge of Process Validation requirements
  • Demonstrated mastery of handling large sets of data, including statistical analysis.
  • A thorough knowledge of the workings of bio-reactors, especially aspects concerning mass transfer and mixing times.
  EOE/DFW