Manufacturing Scientist

PE Global is recruiting for a Manufacturing Scientist, Drug Substance on behalf of our biopharmaceutical client in Dublin. This is an initial 24-month contract, hybrid role.

The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used to produce commercial and clinical drug substance. This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, inspection, process monitoring, and process troubleshooting for manufacturing activities.

There is strong emphasis on AI driven continuous process improvements with this role. The position also fosters effective cross‑functional working relationships with internal and external groups in technical operations, process development, analytical sciences, and quality assurance ensuring sufficient technical oversight of commercial processes. The successful candidate will also be responsible for providing support for regulatory submissions related to commercial and clinical products manufactured at CMOs.

• Providing technical and scientific direction for ongoing commercial drug substance manufacture at CMOs.
• Providing technical direction for the identification and implementation of process optimisation initiatives as well as efficiency and capacity improvements at CMOs, using AI tools where applicable.
• Providing significant technical depth to support continuous process improvement to maximise yield and lower cost of goods (CoG’s).
• Partnering with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle.
• Overseeing process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification).
• Supporting the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites.
• Communicating operational status of CMOs regularly to management, at the appropriate level of detail, through written documents and both formal and informal oral presentations.
• Up to 20% of international travel may be required for this role.

• Minimum of 5 years’ experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on drug substance (DS).
• High level of technical expertise in DS pharmaceutical manufacturing across multiple processing areas.
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
• Broad experience of technology transfer, process validation management, and continuous improvement.
• Effective communication skills to enable successful relationships with both internal and external stakeholders.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Minimum undergraduate degree in a scientific discipline (Biochemistry, Chemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field.
• Experience with AI and AI related tools for continuous improvement projects is desirable.

• Knowledge of drug substance upstream and downstream unit operations.
• Knowledge of basic statistical principles and exposure to statistical software packages (e.g., Minitab, JMP).
• Exposure to/experience of project management principles and tools.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Paul Wheatley on  or alternatively send an up‑to‑date CV to

*** Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***