Manufacturing Scientist – Sterile Drug Product (MS&T)
Role Type: 12-month contract role (Possibility of Extension)
Location: Dublin
About the Company:
Innopharma Technical Services, part of Innopharma Group, is seeking a Manufacturing Scientist to provide support to our multinational pharmaceutical client site based in the Dublin area.
About the position:
The Manufacturing Scientist will provide scientific and technical expertise to support GMP sterile drug product manufacturing, with a particular focus on parenteral and fill-finish operations within the Manufacturing Science & Technology (MS&T) function.
The role will support technology transfer, new product introduction, process scale-up, process validation and ongoing commercial manufacturing activities, ensuring that manufacturing processes are robust, controlled and compliant with applicable GMP requirements and regulatory filings. Working within cross-functional and global technical teams, the successful candidate will provide technical leadership and scientific input across process development, technology transfer, process performance monitoring, manufacturing investigations and continuous improvement initiatives.
The role will also contribute to facility and manufacturing readiness, technical documentation, regulatory submissions and the implementation of new technologies and process improvements.
Key Responsibilities:
- Provide scientific and technical support to GMP sterile drug product manufacturing operations, ensuring robust, compliant and controlled processes.
- Support and lead technology transfer, process introduction and scale-up activities, ensuring successful transfer of new and lifecycle products into commercial manufacturing.
- Support process validation, PPQ, equipment and material qualification, and Continued Process Verification (CPV).
- Execute process characterisation, optimisation and troubleshooting studies, applying DoE, QbD, FMEA and statistical tools to improve process robustness and performance.
- Provide scientific input to deviations, investigations, root-cause analysis, CAPAs and product impact assessments.
- Support process changes, change controls and implementation of new technologies or advanced process controls.
- Author and review technology transfer plans, validation protocols, technical reports, SOPs and CMC regulatory documentation.
- Work closely with Manufacturing, Quality, Engineering, Automation, Validation and global MS&T teams to deliver technical projects and continuous improvement initiatives.
- Maintain GMP compliance, support regulatory inspections and audits, and act as a technical SME for sterile manufacturing processes, including aseptic filling, sterilisation, sterile filtration, isolator technology and lyophilisation.
Preferred Experience:
- Degree in Biochemistry, Chemistry, Chemical/Bioprocess Engineering, Biology or a related scientific discipline, together with relevant 5+ years of experience in GMP pharmaceutical or biopharmaceutical manufacturing.
- Experienced in parenteral operations including aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, and fill-finish operations.
- Strong knowledge of global regulatory requirements, especially EU GMP guidelines and FDA CFR guidelines, related to the design and control of these processes.
- Experienced with the execution of technology transfer and scale-up projects for commercial drug product manufacturing processes.
- Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
- Proven ability to lead complex investigations relating to equipment, processes and systems associated with aseptic manufacture of drug products.
- Experienced in sourcing and qualification of raw materials, excipients, single-use systems, and primary packaging components.
- Demonstrated ability to influence work cross-functionally in a matrix environment during startup and into commercial manufacture.
- Excellent organisational skills, data science knowledge, and statistical skills are required.
Problem-solving and project management ability, as well as lean manufacturing experience are desired.
Note:
- Due to the nature of the business, additional duties may be assigned from time to time.
- All applicants must be eligible to work in Ireland on a valid work visa for the duration of the contract.
- All applicants must be willing to work in shifts, if required.
