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Scientist - Drug Product Process Development

  1. England, South East
Berkshire
  1. Contract
Competitive
  1. CAPEX Projects
36918
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Scientist,Drug Product Process Development - Berkshire, England - 12 Months Contract

We are looking for an experienced Scientist - Drug Product Process Development  for a fantastic 12 months contract based in Berkshire.

You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval.
  • Define and select drug product manufacturing processes and parameters for clinical manufacture.
  • Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organisations, as part of a project team.
  • Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc)
  • Capture and analyse critical manufacturing process data for process understanding and process characterisation
  • Perform process risk assessments
  • Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products),
  • Define the investigational medicine product preparation process in clinical trials.
Requirements:
  • Extensive experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
  • Experience within the bio pharmaceutical industry is an advantage.
  • Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) Is an advantage.
  • Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimisation is an advantage.
If this role is of interest to you, please apply now!
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