Reagents Specialist

Your new role

The Reagents Specialist will be responsible for the management of the assay formulated reagent designs throughout development, transfer to manufacture and scale up.

• Management of the assay reagent designs and handling studies and aiding QC test method development, implementation, and risk management for effective manufacture.
• Support R&D, QC and Operation departments to meet corporate goals.
• Leading standardised chemical formulation calculations and being the authority on applied chemistry principles within the business, acting as a mentor to the team.    
• Working collaboratively with both internal and external parties to ensure high level critical to quality control of the formulated reagents both at R&D, Commercial manufacture and scale up.
• Authority figure in applied chemistry principles and their application, particularly around formulation and chemical calculations.
• Reagent and chemical safety, risk management and regulatory oversight
• Maintaining the QMS and company compliance to ISO13485 / 21 CFR Part 820 level

What you need to succeed

• Educated to degree level in relevant scientific field, PhD would be desirable
• Proven relevant technical experience within commercial applied reagent/chemistry related role.
• Technical experience in Molecular assay development and optimisation – particularly PCR, in vitro diagnostic product development, designing multiplex PCR assays and complex chemical formulation calculations.
• Management of external CMOs within the reagent supply chain.
• Product Verification & Validation experience and working to Quality Management & Regulatory framework
• Experience working within ISO13485 and/or 21 CFR Part 820
• Strong applied chemistry laboratory-based background
• Experimental design, data analysis and problem solving.
• Experience in working with microorganisms to containment level II