Job Overview:
We are seeking a talented Qc Bioassay/Biochemical Assay Scientist to join our team. The successful candidate will be responsible for performing analytical method transfer, validation and GMP routine analysis.
Key Responsibilities:
* Perform cell culture techniques including cell banking, cell revivals, and routine passaging of adherent and suspension lines.
* Participate in QC risk assessments, including quality risk assessment and EHS risk assessment.
* Develop training material for the QC bioassay/biochemistry laboratory personnel.
* Act as a trainer for analytical methods and procedures.
* Lab scheduling and planning for routine testing, investigational testing, and projects.
Requirements:
* Third level BSC degree in related science/quality discipline required.
* Previous experience in a Quality Control/GMP environment.
* Experience with aseptic techniques and operation of a Biosafety Cabinet (BSC).
* Experience with cell culture techniques is desirable.
* Knowledgeable of FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable.