Duration: 12 months, with possibility of extension
Location: Dublin
Onsite Requirements: Initially 3 days/week onsite, with increased flexibility as adept;
Role Overview: This role provides critical process development support for New Product Introductions (NPI) and Lifecycle Management (LCM) changes. The successful candidate will serve as a Process Development SME, accountable for successful product transfers from initiation through line characterization, engineering studies, process performance qualification, and regulatory approval. They will also offer technical support to biologics drug product manufacturing and troubleshoot issues related to drug substance freezing/thawing, formulation, filling, lyophilization, inspection, and transportation.
Key Responsibilities:
- Lead development of validation plans and process performance qualifications for vial and syringe filling.
- Ensure compliance with all policies, procedures, and regulations (FDA, EU, international standards) for tech transfer activities.
- Participate in process validation cross-functional teams, delivering against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Act as a responsible point contact for transfer projects, communicating actively across functions and sites.
- Assist in deviation and exception resolution, root cause analysis, and contribute to product quality assessments.
Essential Skills:
- Product validation experience (not equipment validation).
- Manufacturing expertise.
- Syringe/vial filling, process validation, PPQ, and process characterization.
Desirable Skills:
- Experience in biologic/protein manufacturing or with powder/tablet forms.
- Strong skills in applying engineering/scientific principles to protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
- Knowledge of protein biochemistry.
- Project management skills.
- Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
- Demonstrated leadership in cross-functional teams.
Qualifications:
- Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem-solving ability and excellent oral and written communications skills.
- Doctorate or Masters in Science or Engineering preferred.
Additional Notes:
- Moderate international travel may be required.
- Candidate must be prepared to participate in 24/7 support once or twice a quarter (approx. 1-2 weeks at a time). 35% shift commitment (2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off), with occasional shift work for NPIs/LCMs.
