API Team Lead

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Job Description

API Team Lead - Grange Castle

Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as an API Team Lead.

Takeda's presence in Ireland was established in 1997 and our Irish operations have played an important role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.

How you will contribute:

• Lead the manufacturing of new product introductions designated for P2 at TILGC with the support of manufacturing and tech transfer teams.
• Participate in problem identification, and change projects in cooperation with other teams and services, Leading causes analysis investigations. Continuous improvement with a cross is a core activity.
• Investigate quality events as they arise and prepare deviation reports using site Trackwise system. Identification and implementation of required CAPAs
• Owner of change controls within site Trackwise system and management of tasks promptly across teams.
• Complete required documentation relating to development and manufacturing activities. Such documentation would include (but not be limited to) BMRs, SOP and Logbooks
• Main partner in development of electronic batch records with automation and manufacturing teams.
• Perform responsibilities as directed in whatever area of manufacturing operations they are assigned. This would include (but not be limited to) API batch processing, utility monitoring and waste management.
• Manage manufacturing operations (including all control system 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.
• Provide leadership to manufacturing personnel and ensure all manufacturing activities are performed following current Good Manufacturing Practices (cGMPs). Ensure that GMP standards are being maintained by team members.
• Promote and encourage teamwork within the manufacturing team and with other TILGC staff. Regular two-way communication is considered to be competency.
• Maintain discipline in the manufacturing area and ensure that plant operations are supervised.
• Build daily manufacturing schedules ensuring that all stages of manufacturing are documented and any process deviations recorded promptly.
• Ensure that the manufacturing and ancillary facilities are operated to optimum efficiency and that changeovers of both equipment and production areas are carried out.
• Work with the manufacturing team to establish department goals. Manage this programme to deliver high achievement based on each person's personal, department and site goals
• Contribute to the introduction of new processes and the execution of process validation by and under the direction of relevant support personnel.
• HR management of the manufacturing team including responsibility for - execution of the performance management programme - management of TMS

Environmental, Health & Safety

• Foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an important part of the business.
• Follow all safety policies, procedures and regulations.
• Notify the P2 Technology Transfer Manager/Designee (or other appropriate responsible person) 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 all safety investigations are investigation and reported promptly after an event.
• Participation in HAZOP studies for processes within the manufacturing area

Quality Systems and GMP

• Prepare reports about deviations and investigations.
• Participate in auditing programmes but about contracted engineering and related services.
• Notify the Technology Transfer Manager/Designee (or other appropriate responsible person) of any deviations from defined manufacturing processes or other established procedures. Any abnormal occurrences or observations should also be reported.
• Produce documentation associated with their activities by cGMP, Health and Safety and Environmental regulations or management systems.
• Ask, if in doubt, about any practice or unusual finding.

Training

• Ensure that staff are well trained to safely accomplish their roles. Develop training for relevant personnel with a focus on direct operational and technical support personnel.
• Lead participate in all training and assessment activities (internal and external) about themselves, contractors or other employees.
• Preparation and delivery of training materials.
• Ensure completion of all SOP training and assessment tasks.
• Ensure that all training and assessment is promptly recorded for themselves and other relevant personnel following TILGC procedures.
• Maintain their base. Keep up to date with all current trends and legislations.

General Responsibilities:

• Participate in any training projects.
• Guide and promote the corporate values of Takeda-ism within the workplace.
• Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an important part of the business.
• Ensure that Unplanned Event Forms are completed promptly after an event.
• Ensure completion of all SOP, reading, training and assessment.
• Other tasks and directed by the relevant Manager or other Officer appointed by the Board of Directors.

What you bring to Takeda:

Role:

• Knowledge of API processing techniques and unit operations would be essential.
• Experience a supervisory role in a regulated manufacturing environment.
• Experience handling and working with hazardous chemicals is necessary .
• Experience with automation control systems.
• Experience of new product introduction.
• Documentation experience is necessary
• TRACKWISE system experience is necessary .
• Experience with Automation and production allowing systems such as MES
• Excellent planning, scheduling, and prioritisation ability
• Safety focused.
• Degree or 3rd level technical qualification in science, chemistry, engineering, or equivalent.

What Takeda can offer you:

• Competitive salary and performance-based bonus
• Employer retirement plan contributions
• Employee Stock Purchase Plan
• Revenue approved profit share scheme
• Employer funded income protection
• Employer funded private medical insurance with dependants' cover
• Employer life insurance contributions
• Electric charging points available at parking locations
• Employee Assistance Program
• Wellbeing and engagement teams
• Takeda Resource Groups
• Flexible working arrangements
• Family friendly policies
• 26 vacation days plus additional days for service milestones
• Coaching and mentoring
• Educational programs and formal training
• Development opportunities
• Humanitarian volunteering leave options
• Subsidized canteen
• Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals

More about us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

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