Manager, P2 Manufacturing Operations - Grange Castle
Company: Takeda Pharmaceutical
Posted on: June 22, 2022
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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
- 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
- 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
- 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
- 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
- Notify EHS and Site Leadership (or other appropriate
responsible person) in a timely and comprehensive manner of
- 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
- Proactively participate in auditing programmes as required but
particularly in relation to contracted engineering and related
- 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
- 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
- An honours degree in Science, Engineering or related
- 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
- Proven experience in a supervisory role in a regulated
- 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
- Collaborative approach to meeting goals. Ability to develop
positive working relationships with manager peer group and with
- 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
- Attention to detail is critical.LocationsGrange Castle,
IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
Keywords: Takeda Pharmaceutical, Dublin , Manager, P2 Manufacturing Operations - Grange Castle, Executive , Dublin, California
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