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Details
Senior Technology Transfer Specialist
| Reference: | SMC3958 | Location: |
Dublin |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Process Engineer
We’re currently recruiting for an exciting opportunity with a Bioharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
- Development of characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
- Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
- Collate and report on relevant shipping and filter validation.
- Assist in deviation and exception resolution and root cause analysis.
- Contribute to product quality assessments and process flow documents.
- Third level Bachelor’s degree in science, engineering or equivalent discipline with 5 years experience in a commercial manufacturing or NPI role, advanced qualifications are beneficial
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity). Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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