Opportunities for permanent roles in a range of business sectors

Senior Scientist I (QC and Manufacturing Specialist)

Focussed primarily on the development of materials, production methods and QC inspection processes from late-phase R&D to pilot manufacturing transfer, this hands-on role will involve significant planning and execution of day-to-day manufacturing processes for all Erba Molecular IVD assay products. The role will leverage in-depth practical knowledge of incoming material QC, reagent formulation and final QC definition, to support production transfer of a range of materials and processes including sample preparation chemistries, DNA amplification and lyophilisation processes. 

Key Responsibilities

  • Provide scientific leadership in QC method development and execution as a key interface between R&D and Operations teams
  • Develop manufacturing batch recording processes and procedures
  • Day-to-day prototype-pilot manufacturing process execution within the production labs
  • Ensure adherence to principles of GMP of Good Documentation practices as a local expert
  • Contribute to manufacturing and product FMEA and Risk Management assessment
  • Support QA/RA in troubleshooting and root-cause analysis of non-conforming materials and products

Support all Scientific and Engineering teams in product Design History File, Technical File and Manufacturing datapack creation.

Person Spec

Practical Abilities:

  • Must demonstrate excellent laboratory techniques in a molecular biology setting
  • Must have experience in both design of, and working to, SOPs and Work Instructions
  • Must be comfortable working with MSWord/ Excel for data analysis and reporting

Knowledge/Experience: 

  • Ideally 5 years industry experience working in late-R&D/ production-based development environment
  • Relevant degree
  • Experience in manufacturing and/or QC method development
  • Experience working to ISO13485 and IVD product development processes

Key Skills:

  • Molecular biological reagent preparation, clean production workflows and aseptic techniques
  • Creation of material/ product specifications
  • Incoming material and finished product QC
  • Statistics and creation of statistical sample plans highly desirable
  • Manufacturing stock control

Organisation/Administration:

  • Able to organise and prioritise multiple strands of simultaneous activity to meet tight deadlines
  • Analytical mindset, with high attention to fine detail
  • Quality focussed