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Bioassay Scientist – Biopharmaceuticals - Excellent Salary + Benefits

Job Reference: 10374-LH

Contract type:
Full Time

Duration:
Permanent

Location: North Wales / North West / Cheshire

We are recruiting for an experienced Bioassay Scientist on behalf of one of the top biopharma organisations in the UK. This role reports into the Analytical Development Bioassay Manager.  The main purpose of this role is to development new and current assays, via delivering effective bioassay development and testing to support therapeutic Toxins and other Biological products developed and in-licensed by my client.

The Responsibilities

  • Design, development and validation of effective fit-for-purpose and robust biological-response bioassay (including in vitro cell-based assays, binding and immunoassays, BoNT protease activity assays) to effectively support of Biologic products developed and in-licensed by the company
  • Support implementation of effective bioassay strategies and technologies, performing the development, validation and testing using bioassays that appropriately reflect product mode-of-action in vitro, in support of batch release, stability and product characterisation testing (including support of formulation and bioprocess development/optimisation); from new drug candidate selection, to pre-clinical (pharmacology & toxicology), clinical development, transfer to Manufacturing/QC, and commercial product testing support (e.g. investigations)
  • Support effective DOE for assay design/optimisation, implementation of appropriate control testing strategies (QbD) in co-ordination with analytical and bioprocess development requirements
  • Support assay validation in accordance with ICH guidelines (to support cGMP testing), and regulatory documentation to support product development plans, briefing documents and CMC documentation, as required
  • Support effective pre-clinical and clinical development study requirements and the transfer of assays to operations in-house and with third party contractors
  • Support of new facilities, maintenance of in-house cell-culture and assay development laboratories
  • Support of novel (binding, reporter-gene and/or other format) assay requirements, with growing understanding of scientific and regulatory requirements for biologics product development

The Requirements

  • Mammalian cell culture
  • Experience of working with cell-based assays
  • ELISA
  • Immunoassays
  • Molecular biology
  • Transfection skills
  • Proven knowledge and technical capabilities in core areas of bioassay development, implementation, validation and testing for biologics products
  • Biopharmaceutical R&D industry experience working in technical bioassay teams
  • Understanding of regulatory aspects appropriate to conduct of work and study integrity within product development
  • Communication skills – effective reporting and presentation of bioassay results, across CMC teams, Analytical Development group and Biologics Development department

In return for this skill-set you will be rewarded with a generous annual salary, benefits package and recognised career progression within a growing and forward-thinking organisation.

Apply Now

Liz Holdsworth
e-mail: info@kinetica.co.uk
Telephone: 0113 2617181

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