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 cGMP 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.
- Strong technical expertise in downstream processing, including manufacturing troubleshooting and process optimization.