Technical Transfer Senior Lead

2 weeks ago

Dublin, Ireland Morgan McKinley Full time

Tech Transfer Lead - Biologics Drug Product

Location: Dublin, Ireland

Department: Process Development

Job Type: 12 months, with the possibility of an extension

Are you a seasoned Process Development expert with a strong background in biologics drug product manufacturing? We are looking for a dedicated and experienced Tech Transfer Lead to join our team, driving new product introductions (NPI) and lifecycle management (LCM) changes in a sterile manufacturing environment.

About the Role

This is a critical product leadership role where you will be instrumental in the success of product transfers, with a significant focus on Process Performance Qualification (PPQ). You will act as the primary Process Development SME for NPIs, from initiation through to line characterization, engineering studies, and regulatory approval. The position requires a deep understanding of sterile processing and technical troubleshooting for parenteral products.

Key Responsibilities

- Lead NPIs to vial and syringe departments, and serve as the Process Development SME for these products post-transfer.
- Be accountable for the success of product transfer projects, ensuring they progress through all phases to regulatory approval.
- Provide expert troubleshooting solutions for drug substance freezing/thawing, formulation, filling, lyophilization, inspection, and transportation.
- Apply process development expertise to areas such as sterile processing, process characterization, tech transfer, and validation.
- Develop validation plans and process performance qualifications for vial and syringe filling.
- Ensure all process validation activities adhere to required policies, procedures, and international regulations (FDA, EU).
- Act as the responsible point contact for transfer projects, collaborating across functions and sites.
- Contribute to deviation and exception resolution, root cause analysis, and product quality assessments.

Basic 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.
- Strong knowledge of cGMPs and other worldwide regulatory requirements.
- Excellent problem-solving ability and communication skills.

Preferred Qualifications

- 5+ years of experience in Commercial Protein Drug Product (DP) processing, specifically in areas like sterile processing, process characterization, tech transfer, or validation.
- Strong skills in applying scientific and engineering principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
- Knowledge of protein biochemistry and chemical/physical stability.
- Proven project management skills and ability to lead cross-functional teams.
- Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.

Additional Notes

- The role requires participation in a 24/7 support shift pattern (2 days on, 2 nights on, 4 days off) once or twice a year for 1-2 weeks at a time.
- This is a 35% shift rate applies.
- Moderate international travel may be required.

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