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Plant Technologist Regenerative Medicines

Apply Now Job ID R0004198 Date posted 09/03/2018 Location:Dublin, Ireland

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Job Description

JOB PURPOSE:

Reporting directly to the Team Lead Regenerative Medicines, the main purpose for this role is to perform GMP manufacturing operations for a strategic cell therapy product in Takeda’s new regenerative medicines facility in Grange Castle, Ireland (TILGC).

MAIN RESPONSIBILITIES:

  • Scope includes aseptic regenerative medicine manufacturing in a clean room environment including cell therapy products.
  • Execute production activities: cell culture, cleaning, environmental monitoring, preparation of media and reagents according to cGMP for aseptic production and biological products.
  • Complete daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs, and records of equipment and batches as required.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Ensure all processing equipment and materials necessary are available, maintained and qualified as required for the different manufacturing activities.
  • Ensure the integrity and quality of the products produced in compliance with operating procedures to meet all cGMP, regulatory, and safety requirements.
  • Support material management activities (purchase, reception, storage, etc).
  • 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.
  • Support investigations in manufacturing and technical deviations.
  • Ensure the strongest environmental performance possible by proactively and constantly improving control strategies and engagement in own area of responsibility.
  • Support achievement of overall operational readiness schedule adherence for the new regenerative medicines facility
  • Other duties as required and directed by the Team Lead Regenerative Medicines, TILGC.

General Role Responsibilities:

  • Support a culture of open communication, fairness and transparency.
  • Participate in required training and qualification activities.
  • Support continuous improvement mindset at TILGC.
  • Support effective performance management and participate in multi-discipline shift huddle and shift handovers.
  • Perform all operations in accordance with Takeda 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.
  • Adopt the corporate values of Vision 2025 and Takeda-ism within the workplace.

EDUCATIONAL REQUIREMENTS:

  • Required: laboratory / pharmaceutical manufacturing technologist
  • Science, Engineering or BioChemistry degree or other relevant field of expertise an advantage

RELEVANT EXPERIENCE/CRITERIA:

  • At least 3 years’ experience in pharmaceutical manufacturing in the field of aseptic manufacturing operations.
  • Manufacturing experience in biopharmaceutical operations, preferably involving cell cultures or Regenerative Medicines.
  • Desirable: strong background in cell / tissue culture, preferably with mammalian cell lines (human or animal) and  primary cell culture
  • Detailed knowledge of aseptic manufacturing operations, as well as Quality and HSE. Familiar with EU GMP regulations specific to aseptic manufacturing.
  • Experience in electronic quality management and document systems (EQMS, EDMS), manufacturing execution systems (MES) and SAP an advantage
  • Basic knowledge of MS Office applications
  • Flexible, eye for detail, tidy, neat and organised
  • Working hours from Monday to Sunday, including bank holidays
  • Strong Quality orientation and safety focus.

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