Goodwin Biotechnology

Scope of Function: Provides Bioanalytical support with the execution of existing analytical techniques, analyzing data and resolving technical issues.  Performs qualification and validation of new or existing assays. Assists in the stability studies.

Reports to: Senior Manager, QC Analytical

Specific Duties:

  • Understand and perform bioanalytical techniques including, but not limited to, SEC-HPLC, ELISA, cIEF, CE-SDS, A280, pH, Cell based Assay and visual inspections
  • Create or revise departmental SOPs
  • Ensure all stability chambers and equipment are properly selected, qualified, monitored and maintained in accordance with regulations, standards and company policies/procedures
  • Keep Analytical area in a tidy, organized and in a sanitary condition at all times
  • Execute method qualification/validation protocols, transfer protocols and, prepare reports
  • Excellent verbal and written communication skills
  • Assist in ordering/inventory of lab supplies
    • Subject Matter Expert regarding bioanalytical technique (Cell based Assay, SEC-HPLC) and
    • Contributes to related training
  • Monitor compendia and other standards to ensure procedures and processes are current with industry standards
  • At the request of Quality Assurance Department, assist in vendor audits
  • Assist in writing Deviations, OOS and Investigation
  • Maintains currency with FDA, EMA and other CGMP standards and industry trends
  • Occasionally require to work after hours and weekend and may require to travel for business

Education & Experience Required:

  • BS in a scientific discipline
  • Extensive experience, (minimum three to five years) working in a FDA/EMA regulated environment
  • Excellent writing skills, judgment, integrity, investigation (as in OOS), ability to work independently