logo

Select Sidearea

Populate the sidearea with useful widgets. It’s simple to add images, categories, latest post, social media icon links, tag clouds, and more.
hello@youremail.com
+1234567890

QC Manager, Analytical Development

Rate : Negotiable
Job Type : Permanent
Apply Now

QC Manager, Analytical Development

We are looking for a QC Manager to develop and run QC analytical methods to characterise product quality attributes of biopharmaceuticals.


    Responsibilities:
  • Develop QC analytical methodologies and create SOPs for product quality analysis of monoclonal antibodies and novel biologics to support the client’s portfolio.
  • Technology Transfer to Contract Manufacturing Organisations.
  • To provide CMC manufacturing records and documentation to support regulatory submissions.
  • To communicate progress and identify risks and issues arising to the Group Leader of Analytical Development as appropriate.
  • Represent the Analytical Development function on internal and external project teams.
  • To maintain awareness of, and ensure compliance with the client’s policies and procedures.

    Job requirements:
  • PhD in relevant discipline or BSc/MSc with equivalent industrial experience.
  • Proven track record of analysing product quality attributes for biopharmaceuticals.
  • Proven track record in analytical method development for mAbs and biologics.
  • Proven track record in maintaining CMC documentation within a Quality Management System.

    Skills & knowledge:
  • Comprehensive knowledge of qualifying (essential) and validating (desirable) analytical methods to support biopharmaceutical development.
  • Highly competent in liquid chromatography (reversed-phase, size exclusion, IEX) and capillary electrophoresis technologies.
  • Experience in mass spectrometry techniques, including peptide mapping and intact mass analysis, desirable.
  • Ability to work independently to establish and run qualified/validated methods and to perform analytical testing as required.
  • Highly organised, able to prioritise work, work well under pressure and meet deadlines
  • Excellent communication and organisational skills
  • Development and implementation of analytical capabilities
Apply Now
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.