MSci Pharmaceutical Technology Specialist応募後で応募 求人ID R0051314 掲載日 10/22/2021 Location:Dublin, Ireland
- Leads the technology transfer of 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
- Lead the cross-functional technology transfer team with the scope of regenerative medicine manufacturing
- Provide validation expertise in the Alofisel® Production area ensuring compliance with current industry regulations, guidelines and trends.
- Delegate tasks and communicate priorities to team members
- Develop and own 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.
- Lead the process validation.
- 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 and clinical trial material
- 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.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- Science, Engineering or BioChemistry degree or other relevant field of expertise.
- At least 5 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
- Experience of aseptic GMP manufacturing and filling is considered essential.
- Manufacturing experience in biopharmaceutical operations involving cell cultures or Regenerative Medicines and VHP decontamination an advantage.
- Previous Supervision/management experience is an advantage
- Excellent project management skills, Project Management Professional (PMP) is a plus
- Experience in operational excellence Lean/Six Sigma, Green Belt Certification is an advantage
- Excellent planning, scheduling and prioritization ability
- Excellent documentation skills and attention to detail.
- Strong Quality orientation and safety focused.
- Ability to work under pressure & managing conflicting tasks at the same time