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Biotech Tech Transfer Lead, Dublin

1 month ago

Dublin, Ireland TN Ireland Full time

Employment Type: Contract

Work Location: Site Based / Hybrid

Experience: 5+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.

This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.

You will establish yourself in a product lead role where the majority of input provided will be leading process performance qualification (PPQ).

In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization.

Responsibilities include:

  1. Lead new product introductions from a Process Development perspective and serve as the Process Development SME for these products following completion of the transfer.
  2. Be accountable for the success of the product transfer project from initiation to transfer, through line characterisation, engineering studies, process performance qualification, and ultimately to regulatory approval.
  3. Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
  4. Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation.
  5. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
  6. Report to the Process Development Senior Engineer.
  7. Moderate international travel might be required during the course of the project.
  8. Develop validation plans and process performance qualifications for vial and syringe filling.
  9. Ensure all activities within any given process validation adhere to required policies and procedures, including safety and training.
  10. 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 processes related to technology transfer.
  11. Participate in process validation cross-functional teams at the site to ensure adherence to required policies and procedures and deliver against organizational goals and project milestones.
  12. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
  13. Actively communicate across functions and sites and be a strong collaborator with all functional groups at the receiving site, sending site, and corporate functions.
  14. Act as the responsible point of contact from the ADL site for the transfer project for drug product teams and Global Operations Teams.
  15. Assist in the development of any existing validation program to ensure continued compliance with the necessary regulations and contribute to site validation guidance documents.
  16. Collate and report on relevant shipping and filter validation.
  17. Assist in deviation and exception resolution and root cause analysis.
  18. Contribute to product quality assessments and process flow documents.

Requirements

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 communication skills.

Product validation experience (not equipment validation).

Manufacturing experience.

Syringe / Vial filling / Process Validation / Performance Qualification / PPQ Process Characterisation.

Biologic or protein manufacturing experience.

Please note: candidates should focus on product/process validation rather than equipment validation.

Need to know how the product works and operates.

Preferred Qualifications

Doctorate or Masters in Science or Engineering.

5+ years of 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), and/or lyophilisation processes.

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.

Excellent communication skills are essential for this role.

Package

Minimum 12 month contract with the possibility of an extension.

Onsite Requirements:

Core hours: 08:30 to 17:00.

Prepared to be onsite more regularly at the start to integrate into the team.

Requirement long-term to be onsite 3 days per week & come onsite when needed.

Shift Patterns:

Once every quarter, there is a need to support shift work based on the support of PPQs and engineering runs.

As the business has changed, we will do more regular shift work and will require support from the team.

Shifts are 2 days on and 2 nights on and 4 days off and repeat like that.

Shift hours: 07:00 am to 07:00 pm and 07:00 pm to 07:00 am @ 35% shift rate.

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