Position: Principal Scientist Location: Dublin, Ireland (Hybrid) Contract Duration: 12 Months
Lead the science behind life-changing biologics.
Own the downstream processes that deliver medicines to patients worldwide.
Join a highly technical and collaborative biologics manufacturing team, where your expertise directly impacts product quality, regulatory success, and patient supply.
Key Responsibilities
Lead troubleshooting and provide technical expertise for downstream GMP biologics manufacturing, including chromatography, ultrafiltration, virus filtration, and virus inactivation.
Drive process optimization and continuous improvement initiatives to improve yield, robustness, and cost of goods using data-driven approaches.
Act as process subject matter expert for regulatory inspections, audits, and global health authority interactions, including query responses.
Represent manufacturing during audits, preparing and defending technical documentation and process decisions.
Lead manufacturing investigations, deviation resolution, and implementation of improvements via change control and CAPA.
Collaborate cross-functionally with upstream, MS&T, QA, QC, Engineering, and Regulatory teams to support commercial manufacturing.
Mentor junior scientists and serve as the senior technical resource within the downstream team.
Experience & Qualifications
BSc (or equivalent) in a scientific or engineering discipline.
6+ years' experience in drug substance manufacturing technical support within a GMP biologics environment (exceptional candidates with 5 years of strong downstream experience may be considered).
Strong technical expertise in downstream processing, including manufacturing troubleshooting and process optimization.
Demonstrated knowledge of c GMP compliance and experience supporting regulatory inspections, audits, and global health authority interactions.
Proven ability to author, present, and defend technical and scientific approaches in both written and verbal form.
Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in cross-functional, matrix organizations.
Ability to influence stakeholders without direct authority, balancing product quality, compliance, and operational requirements.
Lead, innovate, and make a difference - your expertise in downstream biologics manufacturing will help ensure safe, high-quality medicines reach patients globally.
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