Senior Downstream Scientist

108573
  • 0.00
  • D, IE
  • Permanent

SENIOR DOWNSTREAM PROCESS DEVELOPMENT SCIENTIST

Location: Dublin

ABOUT THE ROLE

We are seeking a Senior Downstream Process Development Scientist to lead early-stage and MSAT purification process development, from bench and pilot scale through to commercial scale-up.

The role covers multiple modalities, including monoclonal and multispecific antibodies, ADCs, AOCs, recombinant proteins, peptides, enzymes, viral vectors and mRNA products.

KEY RESPONSIBILITIES

  • Design, develop and characterise downstream purification processes.
  • Lead chromatography activities using affinity, IEX, SEC and multimodal techniques.
  • Develop clarification, TFF, ultrafiltration and diafiltration processes.
  • Support viral filtration, viral inactivation and clearance studies.
  • Optimise process yield, purity, robustness and cycle time.
  • Assess scalability, manufacturability and process economics.
  • Evaluate automation, high-throughput and single-use technologies.
  • Troubleshoot unit operations and investigate process deviations.
  • Lead root-cause analysis, CAPAs, change controls and continuous improvement.
  • Prepare protocols, reports, SOPs and CMC documentation.
  • Lead multiple DSP programmes and support technical decision-making.
  • Collaborate with upstream, analytical, quality, manufacturing and formulation teams.
  • Present technical recommendations to clients and internal stakeholders.
  • Mentor junior scientists and support technical training.

REQUIREMENTS

  • PhD with approximately five years, MSc with seven years, or BSc with ten years of relevant downstream processing experience.
  • Strong knowledge of cGMP, CMC development and regulatory expectations.
  • Practical experience with chromatography and membrane-based purification.
  • Strong scientific problem-solving and data-analysis capabilities.
  • Excellent technical writing, documentation and communication skills.
  • Experience leading projects in cross-functional environments.
  • Ability to manage multiple programmes and influence technical decisions.

#DownstreamProcessing #ProcessDevelopment #Chromatography #AKTA #AffinityChromatography #IonExchangeChromatography #SizeExclusionChromatography #TFF #Ultrafiltration #Diafiltration #ViralClearance #ViralFiltration #ProcessScaleUp #ProcessCharacterisation #MSAT #CMC #cGMP #CAPA #RootCauseAnalysis #SingleUseSystems

Holly Groom Researcher

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