Manager, P2 Manufacturing Operations - Grange Castle

Company: Takeda Pharmaceutical
Location: Dublin
Posted on: June 22, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJOB PURPOSE:The Manager of P2 Operations will have oversight and responsibility for the commercial operations in the P2 Ninlaro facility.The initial focus of this role will be on Drug Product and Secondary Packaging manufacture. The role may expand to include API manufacture upon successful technical transfer of Ninlaro API and Ninlaro intermediates.The delivery of manufacturing targets, in compliance with quality, safety and environmental requirements, within cost targets and on schedule is a prime focus for this position. The P2 Manager will direct and manage the work of the plant operations associated with P2 plant at TILGC. The P2 Manager must be capable of working on their own initiative and leading very flexible teams in a demanding, regulated environment.The P2 Manager will be involved in the co-ordination and development of manufacturing systems, procedures, EOPs and SOPs necessary to support GMP and EHS compliant manufacturing. Team building, recruitment and training of the extended P2 manufacturing team will also be the responsibility of the P2 Manager.Specific and varying duties will be given to the P2 Manager in relation to their current assignment but some key tasks and responsibilities are outlined below.RESPONSIBILITIES:

• Perform duties as directed in whatever area of manufacturing operations they are currently assigned to. This would include (but not be limited to)
• Management and support of P2 plant operations personnel with batch processing, utilities and other relevant areas of operation as required
• Management and support of Process Engineers in the provision of direct technical support to manufacturing operations in P2 (both troubleshooting and on an ongoing basis)
• Investigation and reporting in relation to equipment and processing issues technology transfer and associated support both to and from the TILGC site
• Hazard evaluation and control including HAZOPs and Process Reaction Safety analysis
• Ensure that all activities for which they have responsibility are carried out in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health and Safety and Environmental (HSE) Legislation. Play a leadership role, as an individual but particularly through the direction of the P2 plant operation teams;
• Management of plant operations in accordance with current Good Manufacturing Practices (cGMPs).
• Optimisation of processes together with the preparation and execution of process validation programs
• Promote and encourage teamwork within the P2 plant operations group and with other TILGC staff. Regular two-way communication is considered to be a key competency.
• Maintain discipline in the manufacturing area and ensure that P2 plant operations are properly supervised at all times.
• In conjunction with the Supply Chain team, plan manufacturing efficiently to meet necessary manufacturing and shipping timelines. Ensure that schedules are created and implemented in a timely manner and that all stages of manufacturing and plant turnaround activities are accurately documented, and any process deviations recorded.
• Actively manage and 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.
• Work with the P2 plant operation teams to establish department goals. Manage the teams and this program to deliver high achievement based on each person's personal, department and site goals.
• HR management of the plant operation teams including responsibility for execution of the performance management program timely management of TMS
• Ensure that management systems are developed and implemented to maximise the availability, effectiveness and safety of plant and equipment throughout the facility on a continuous basis.
• Continuously evaluate developments in Process and manufacturing equipment and practices and implement related improvement programmes.
• Carry out any manufacturing activities as directed by, and in strict compliance with, the relevant Batch Manufacturing Instruction and Record (BMR) and Standard Operating Procedures (SOPs) or other Protocol.
• Available to participate in 'on call' program and respond to 'call out' as required.Safety
  • Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Adhere fully to all safety policies, procedures and regulations.
  • Notify EHS and Site Leadership (or other appropriate responsible person) in a timely and comprehensive manner of any:
  • Breach of HSE policy, procedure or regulation.
  • Potential hazard which could have a serious impact on safety or result in serious injury.
  • Ensure that Beacon Events and associated investigations are completed in a timely manner after any safety incidentQualitv Svstems and GMP
    • Preparation of reports in relation to deviations and/or investigations, as required.
    • Work collaboratively with the Quality organisation to ensure timelines for closure of all Quality events (Deviations, Complaints, Change Controls, CAPAs, RCAs etc) are completed to schedule
    • Proactively participate in auditing programmes as required but particularly in relation to contracted engineering and related services.
    • Notify the Head of Manufacturing (Small Molecule) (or other appropriate responsible person) in a timely and comprehensive manner of any deviations from defined manufacturing processes or other established procedures. Any abnormal occurrences or observations should also be reported.
    • Generate documentation associated with their activities as required by cGMP, Health and Safety and Environmental regulations or management systems.Training
      • Ensure that staff are well trained to safely and effectively carry out their roles.
      • Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.
      • Lead/actively participate in all training and assessment activities (internal and external) in relation to themselves, contractors or other employees.
      • Preparation and delivery of training materials.
      • Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures. Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.
      • Ensure development plans are in place for team members and are executed on an annual basis
      • Develop cross-training across the plant so that there are back-ups for every roleGENERAL RESPONSIBILITIES:
        • Participate fully in any cross functional training initiatives.
        • Member of the Grange Castle Extended Leadership Team
        • Drive and promote the corporate values of Vision 2025 and Takeda-ism within the workplace.
        • Actively foster, in cooperation with others, an ethos of continuous improvement where AGILE is accepted as an integral part of the overall business.
        • Other duties as required and directed by the Manager, Finance or other Officer appointed by the Board of Directors.EDUCATIONAL REQUIREMENTS:
          • An honours degree in Science, Engineering or related discipline.RELEVANT EXPERIENCE:
            • Experience gained at an API, OSD or Pharmaceutical Packaging facility would be an advantage
            • Background and/or education in area of Cl/Lean would be an advantage
            • Proven experience in a supervisory role in a regulated manufacturing environment.SKILLS/COMPETENCIES:
              • Flexible, willing and positive attitude / mind-set
              • Safety focused.
              • Strong Quality orientation.
              • Ability to work under pressure & managing conflicting tasks at the same time.
              • Ability to work well with others to achieve organisational goals.
              • Collaborative approach to meeting goals. Ability to develop positive working relationships with manager peer group and with senior leaders
              • Comprehensive understanding of pharmaceutical manufacturing processes would be expected.
              • Excellent written and verbal communication skills
              • Excellent planning, scheduling and prioritisation ability
              • Excellent documentation skills and attention to detail.
              • Excellent knowledge of Microsoft products and systems skills.
              • Attention to detail is critical.LocationsGrange Castle, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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