Downstream Scientist (Manufacturing Technology) – 12 Month ContractWe are seeking an experienced Downstream Scientist (Manufacturing Technology) to join a high-performing biopharmaceutical manufacturing environment on a 12-month contract. This role plays a critical part in providing process validation support and ongoing technical oversight for commercial drug substance manufacturing operations.You will work within a highly collaborative, cross-functional setting, partnering closely with Manufacturing, Engineering, Quality, and Regulatory teams to ensure robust, compliant, and efficient downstream processes.Key ResponsibilitiesProvide technical expertise and support for downstream drug substance manufacturing processes, including:Buffer preparationPurification and viral reduction stepsChromatography operationsUltrafiltration, viral filtration and viral inactivation technologiesDrug substance formulation and bulk fillDevelop a strong scientific understanding of the molecule and its associated manufacturing process.Author and review technical documentationLead and execute technical and plant-supporting studies at commercial scale.Identify and implement process improvements (e.g. yield optimisation, cycle time reduction) using data-driven analysis.Provide on-the-floor technical support, including troubleshooting manufacturing issues and leading investigations into process deviations.Act as process SME during regulatory inspections and technical interactions with regulatory agencies.Communicate learnings and outcomes through internal forums and, where appropriate, external scientific meetings.Support continuous improvement initiatives through change control, CAPAs, and Lean programs.Qualifications & ExperienceBSc or equivalent in a scientific discipline.Minimum 2 years’ experience in drug substance manufacturing technical support within the biopharmaceutical industry.Strong knowledge of cGMP requirements and regulatory expectations.Proven technical writing and documentation skills.Excellent interpersonal and communication skills, with the ability to work effectively in cross-functional and matrix environments.Ability to present, defend, and influence technical decisions while balancing product quality and operational needs.Comfortable operating without direct line authority and influencing key stakeholders.Additional InformationThis is an on-site role based in Dublin, Ireland.The position may occasionally require extended hours or on-call support to meet manufacturing needs.
#J-18808-Ljbffr