M

Process Scientist

MSD Malaysia
1 hour ago
Contract
Leinster
Ireland
Overview

Our Biotech facility in Dublin, built in 2018 and fully operational since 2021, plays a pivotal role in the manufacture of the Company's biologics based medicines, including immuno oncology. This position offers an exciting opportunity to join the Manufacturing Science and Technology Laboratory Team as a Process Scientist focused on cell culture technology.

Responsibilities
  • Lead, design, promote and execute experimental design, data analysis and interpretation to resolve complex cell culture deviations using small scale models.
  • Process improvement and troubleshooting with end to end product focus.
  • Execute and optimize upstream bioprocesses using bioreactors, including culture setup and monitoring key parameters.
  • Support the Industry 4.0 initiative by navigating operations in a digital environment.
  • Provide technical support for investigations, new process introduction or change implementation in commercial manufacturing operations.
  • Support global regulatory submissions as needed.
Qualifications
  • A degree (or higher) in Biological Sciences, Chemistry, Chemical Engineering or Biological Engineering.
  • At least two years' experience in the biopharmaceutical industry, preferably in cell culture processing and other upstream activities.
  • Experience in small scale bioreactor models (250ml to 10L) for at least two years.
  • Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling.
  • Experience in designing and executing experimental programs in the laboratory.
  • Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or DesignExpert software).
  • Technical experience in the drug substance manufacture of biological molecules at pilot or commercial scale.
  • Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
  • Knowledge and experience in applying Six Sigma and Lean methodologies.
Required Skills
  • Biopharmaceutical industry experience; bioreactors; cell culture bioreactors; cell cultures; chemical engineering; fluid mechanics; process characterisation; process development (PD).
Equal Opportunity Employer

We are an equal opportunity employer committed to diversity and inclusion in all aspects of employment.

Flexibility

We support flexible working arrangements where possible and encourage candidates to discuss what flexibility means to them during the application process.