As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.

We are currently looking to recruit an Analytics Leader within the Quality Operations group at Keele, Staffordshire, UK. The successful candidate will be responsible for all Analytical aspects relating to method development, evaluation, qualification/validation and transfer for assigned Projects.

Main duties will include:

  • Responsibility for scientific development and evaluation of analytical methods; to include identification and implementation of new assays to meet the developing needs of the Business;
  • Working with technical leads, multidisciplinary teams and clients to determine the optimal technical and scientific approach for ensuring the efficient progression of assigned programmes;
  • Accountability for the scheduling, management and execution of the analytical support to deliver assigned programmes of work;
  • Line management responsibility for a team of analysts;
  • Responsibility for method transfer within the Cobra group or externally;
  • Responsibility for method qualification/validation;
  • Support in delivery of QC testing to meet the needs of the Business;
  • Support of Commercial activities and for working closely with Project Management. 

     

    In addition, this role will provide senior level expert opinion on scientific practice within the Company and will assist management to formulate scientific strategy.

    The applicant must have extensive analytical experience. A proven track record in assay development and validation is essential; a higher degree qualification may be an advantage and the candidate should also be able to demonstrate:

    Broad knowledge of analytics application for both final product and in process samples types with the ability to confidently interpret data, reach sound scientific conclusions, present, discuss and defend data / scientific direction internally, to academic groups and to clients;

  • Understanding of method requirements as per Regulations such as ICH and  EU GMP;
  • Ability to work independently with limited supervision, owning the scientific direction of their work as well as interacting with academic groups;
  • Ability to solve complex problems;
  • Ability to demonstrate strong written and oral communication skills;
  • Line management experience.

    The ideal applicant should possess a Degree in Biochemistry, Virology, Biotechnology, or other appropriate science and a minimum of 5 years relevant postgraduate experience preferably in part within an industrial environment.

     

    Special Requirements:

    The ideal candidate must be highly motivated, and demonstrate strong working knowledge of multiple product types, including trouble shooting capabilities, in vitro cell-based methods, QPCR and immunoassay techniques. Practical experience of assay development and/or assay validation is essential.

    The ideal candidate will ideally have previously published work in peer reviewed scientific journals.

    The applicant will be expected to apply methods to generate data on the quality and stability of compounds in development and to interpret and present data.

    Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Marie Cusworth, HR Administrator, Human Resources, Cobra Biologics email; marie.cusworth@cobrabio.com

                               

CLOSING DATE: Friday 17th June 2016