Quality Systems Specialist – (Ref: NHBR18)

  • Contract
  • Dublin

Website HeadcountGroup Headcount Solutions

Scientist

An opportunity for a Specialist Process Scientist has opened up within a leading Biotech multinational, this is an excellent opportunity to progress your career within a state of the art, dynamic environment.

Responsibilities:

·       Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.

·       Supporting process improvement and troubleshooting with end-to-end product focus.

·       Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations.

·       Authoring and reviewing development operating procedures and technical reports.

·       Supporting global regulatory submissions as needed.

·       Applying LeanSixSigma tools in the Process Sciences group by:

Qualifications and Experience

·       1-3 years’ experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).

·       Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling.

·       Experience in executing experimental programs in the laboratory.

·       Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)

·       Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.

·       Knowledge of and experience in applying Six Sigma and Lean methodologies

·       Desirable evidence of Continuous Professional Development

·       A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering

For more information and a full job spec please email your CV to the link provided.

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