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FORMULATION DEVELOPMENT SCIENTIST (BIOLO

 

Job Reference Number

14592909

Client ID:

RI/GJ36950

Posted On:

May 3 2012

Location:

CONNAUGHT/ULSTER

Job Type:

Permanent

Salary:

NEGOTIABLE

Our client a growing and expanding healthcare company based in the West of Ireland now requires senior experienced Scientists with strong backgrounds in formulation biologics to join their team.

Key responsibilities of the post include:

  • Provide expertise for the screening and selection of biologics drug product formulations, container closure systems and lyophilisation cycles to meet global project team goals
  • Coordinate and support Technology Transfer activities associated with scale up of pilot scale biological drug product manufacturing processes to commercial manufacturing scale
  • Identify and implement appropriate biologics drug product characterisation initiatives to support global projects goals (e.g. QbD, PAT and Risk Assessments) for a range of biological drug products
  • Support pre-Clinical and Clinical Trial supply for a range of biological drug products at different stage of development
  • Act as a technical/scientific resource to support the goals of a dynamic global biologics drug product development team


The ideal candidate will possess:

  • PhD and three or more years of applied experience or MSc degree and five or more years of applied experience in biologics formulation development
  • Practical experience in the development and optimisation of lyophilisation cycles from bench scale to industrial scale Freeze Driers for biological drug products
  • Experience of managing and coordinating technology transfer activities from pilot scale to manufacturing scale for biologics
  • Excellent technical writing and communication skills
  • Experience with GMP regulatory inspections & working knowledge of international GXP’s (GCP/GLP/GMP) for biologics development activities
  • Experience with performing drug product characterisation activities in support of regulatory submissions
  • Knowledge of process control, Quality by Design (QbD), Process Analytical Technologies (PAT), and process validation
  • Experience with interacting in project teams at a Global Level
  • Skilled in the application of scientific design principles to the challenges associated with biological drug product development
  • Working knowledge of fermentation and purification processes
  • Working knowledge of statistical methodologies
  • This role is an excellent career opportunity for a science professional looking to work in or relocate to the west of Ireland.


For further information please or a confidential conversation please contact Michelle Murphy (Regional Manager) Collins McNicholas, Galway on 091-706711 or email: [email protected]