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.
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