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Job Description

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 a Process Development Chemist for 24 months.

Takeda's presence in Ireland was established in 1997 and our Irish operations have played a key 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:

Technology Transfer

• Play a leadership role in the introduction of a new process together with the preparation and execution of process validation programs.

• Be the Subject Matter Expert in technical aspects of the process including assessment of critical parameters, establishment of bases of safety and implementation of control strategies.

• Support cleaning and process risk assessment programs to define manufacturing and cleaning procedures.

• Provide technical support and direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency.

• Conduct laboratory-based experiments to support the Technology Transfer when required.

• Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. 

Quality Systems and GMP

• Perform operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.

• Complete required documentation in an accurate and timely manner. Such documentation would include (but not be limited to) records required by SOPs, Logbooks and Labels as well as HSE records.

• Generate documentation associated with their activities as required by cGMP and review Standard Operating Procedures (SOPs), Batch Manufacturing Instruction and Record (BMRs), Logbooks, Labels, In-Process Test documentation, and other regulatory documentation (Quality, Health & Safety, Environmental) as required.

Safety & Environment

• 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 the Process Development Laboratory Manager (or other appropriate responsible person) in a timely and comprehensive manner of any breach of HSE policy, procedure or regulation.

Training

• Actively participate in all training and assessment activities (internal and external) in relation to themselves, manufacturing personnel or other employees.

• Ensure timely completion of all SOP training and assessment tasks.

• Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.

What you bring to Takeda:

• PhD in Synthetic Organic Chemistry

• 3-5 years experience of working in a Process Development Environment in a Manufacturing Pharmaceutical Facility.

• Experience of supporting an API Technology Transfer.

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