Tech Transfer Lead
- Dublin
- Contract
- Full-time
- 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.
- Product validation experience (not equipment validation).
- Manufacturing expertise.
- Syringe/vial filling, process validation, PPQ, and process characterization.
- 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.
- 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.
- 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.