Scientist, Quality Control

Location
Sarasota, FL, United States
Posted
Jan 01, 2021
Ref
13795557
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.

QC Development Scientist

Key responsibilities:
  • Testing and characterization of protein products to include the design and execution of studies and interpretation of results.
  • Author technical reports and analytical CMC sections in regulatory documents.
  • Development, qualification, remediation, and technical transfer.
  • Author technical protocols, reports and SOPs for analytical methods.
  • Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.
  • Effectively interfacing and collaborating with other functional area colleagues within Process Development to support and advise design of characterization studies, data analysis and communicating results
  • Provide expertise and evaluation of analytical technologies, helping to drive innovation and efficiency within the Process Development function.
  • Provide characterization results and/or authoring sections of clinical trial and marketing applications, helping to refine analytical regulatory strategies.


Qualifications
  • PhD or equivalent experience in Chemical/Biochemical Engineering or related Biological Science with 4+ years of industrial experience in the Biotech industry.
  • Direct experience within an industrial laboratory performing methods development to support biologics quality testing.
  • Demonstrated expertise in mass spectrometry, liquid chromatography, and protein chemistry analysis.
  • Functional understanding of regulatory guidelines with respect to product quality.
  • Proven proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing mentorship to junior staff.
  • Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects.
EOE/DFW