Position Summary:

The primary role of the Senior QC Specialist is to transfer analytical methods from development to Quality Control and conduct cGMP analytical testing for raw materials, in process samples, finished product and stability testing per standard operating procedures. This role will work closely with the QC analyst and the Development group leading the transfer and implementation of analytical methods in Quality Control. This includes but is not limited to the following:

  • Transfer and implementation of analytical methods
  • Develop and implement QC Systems
  • Write and revise procedures
  • Implement new equipment, perform routine maintenance and troubleshoot equipment issues
  • Routine and non-routine testing which includes HPLC, viral assays, bioassays, cell based assays, qPCR and other analytical methods
  • Data analysis, statistical analysis, data management and documentation utilizing GDP  
  • Troubleshoot analytical issues, perform failure investigations, determine and implement corrective actions
  • Provide leadership and training in the lab to junior analyst(s)
  • Completing and reviewing cGMP documentation

Requirements:

  • Bachelor’s degree (or equivalent) in a scientific discipline with 10+ years relevant industry experience; MS in a scientific discipline with 8+ years relevant industry experience; Ph. D with 6+ years of relevant industry experience. 
  • cGMP experience required
  • Bioassay, viral assay and molecular biology (qPCR) proficiency Analytical method transfer and validation experience

Qualifications:

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)