Pharmaceutical Technology Specialist, Cell Therapy
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Pharmaceutical Technology Specialist, Cell TherapyApply Now
Part of the technology transfer team for the introduction of new products designated for the biologics manufacturing facility at TILGC.
Provides technical support for all manufacturing activities associated with the biologics manufacturing facility at TILGC.
Act a subject matter expert (SME) for aseptic processing of regenerative medicine in compliance with GMP and relevant regulatory requirements.
As part of Operational Readiness
Part of the cross-functional technology transfer team with the scope of regenerative medicine manufacturing
Tracking activities on the Tech Transfer Schedule
Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
Planning, implementation and evaluation of experimental programs with regard to the manufacturing process incl. design of experiment, continuous process verification and process capability evaluation.
Assist with the process validation and tech transfer runs.
Support P3 operations team with achieving overall operational readiness schedule adherence.
Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
Accompany and supervise development, transfer, validation and process optimization operations in an aseptic manufacturing environment.
Safeguard the timely and GMP compliant production of registration samples.
Complete required documentation and change controls relating to technology transfer, development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.
As part of production operations:
Manufacturing and process subject matter expert with regard to aseptic manufacturing, bioprocessing and regenerative medicines ; Participate in and support regulatory audits
Support investigations in manufacturing and technical deviations.
Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
Execute, lead and participate in risk assessments associated with technology transfer of the process
General Role Responsibilities:
Support a culture of open communication, fairness and transparency.
Participate in any required training and ensure team members are suitably trained.
Drive a continuous improvement mind-set in line with AGILE program at TILGC.
Advocate team problem solving. Working proactively to positively affect metrics, morale and metrics such as schedule adherence and quality attributes
Drive the implementation of Standard Work amongst team ensuring activities are coordinated and integrated (training, documentation, process improvements, investigation activities etc.) using an inclusive planning system.
Uphold Company Code of Conduct.
Ensure that they themselves perform all operations in accordance with TILGC quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
Travel requirements: Up to 20% during project phase.
Science, Engineering or BioChemistry degree or other relevant field of expertise.
At least 3 years’ experience in Pharma Manufacturing including technology transfer preferably in the biopharmaceutical / bioprocessing field.
Detailed and in-depth knowledge of biopharmaceutical manufacturing operations, as well as Quality and Regulatory Affairs.
Detailed knowledge in experimental design, statistical data analysis and quality by design
Excellent trouble shooting and problem-solving skills
Promoting a culture where diversity and inclusion is part of the DNA of the site
Grange Castle, Ireland
Job ID R0021348