My client a leading Pharmaceutical company now require a NPI Specialist – Technology Transfer to join their expanding team.
The NPI Specialist – Technology Transfer will be involved in the introduction of new products designated for biologic Manufacturing, they will provides technical support for all manufacturing activities and act as a subject matter expert (SME) for aseptic processing of regenerative medicine in compliance with GMP and relevant regulatory requirements.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of NPI Specialist – Technology Transfer
- 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 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.
- 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
- 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
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.