QC Biochemistry Reviewer

Desired Skills: Gel electrophoresis,ELISA,plate based assays,Protein concentration Release,stability and in-process review scheduling and testing.

PE Global is currently recruiting for a QC Biochemistry Reviewer for a leading multi-national Pharma client based in Dublin.

This is a contract position.

Role:

The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The QC Biochemistry Reviewer (Senior Analyst) is responsible for providing technical and laboratory support to the QC analysts in Alexion Dublin specifically working with the team to troubleshoot issues that may arise. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail.  The individual must be able to perform routine tasks with a minimum of supervision.

Responsibilities:

• Perform all lab functions in compliance with cGMP
• Follow written procedures for review of the following tests, as trained and qualified:
• Gel electrophoresis (SDS-PAGE, IEF)
• ELISA and plate based assays (potency and residual assays such as HCP and ProA)
• Protein concentration
• Release, stability and in-process review scheduling and testing.
• Recognize and report aberrant test results and sample conditions.
• Provide QC SME and day to day technical guidance to QC biochemistry analysts
• Training of new analysts in review
• Drive continuous improvement initiatives within the QC department.
• Contribute to investigations/CAPAs in a timely manner.
• Ensure training is current for all job functions performed.
• Complete all required documentation legibly and accurately.
• Drive Right First Time improvements within the lab for documentation

Requirements:

• BSc in Biochemistry or a biological/chemistry science, with 4-7 years’ experience, or equivalent combination of education and experience.
• A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
• Ability to follow written procedures with close attention to detail
• Ability to function with minimal supervision for routine job duties
• A working knowledge of gel electrophoresis and ELISA assays (Softmax software)

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***