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Job Description

About the role:

• Lead/Execute/Own GMP PE activities including but not limited to change controls, deviations, investigations, protocol and report writing, assessments and approvals, including special attributes such as serialization connectivities to TraceLink or relevant CMO/UPI systems, packaging component development, qualification, equipment and process optimization and implementation.  

• Lead ALL commercial (including launch) packaging activities and relevant KPI’s for the assigned CMO/CMO’s and associated products.

• This role is also involved in the development, launch and life cycle management of products’ primary (where filing is not required) and/or, secondary and/or, tertiary packaging components and/or equipment maintenance and engineering. 

• Support internal packaging sites as consultants to ensure above site, CMO and process harmonization.

• Support Packaging Engineer Site Lead in a collaborative team environment.  Manage and deliver project plans, packaging process and container closure standardization/harmonization, OEE optimizations and continuous improvement initiatives.

• Liaison with Takeda External Supply Team members to deliver packaging commitments

• Liaise with Packaging Site Lead, with CMO’s where required or lead CMO discussions where directed by remit and department manager

How you will contribute:

Scope of work includes GLOBAL commercial products’ in the Oncology, Small Molecule portfolio (commercial and pipeline commercial preparations).

• Complete Technical Profile Drawings in compliance with defined attributes and procedure

• Process Owner and /or the Execution Lead, for one or more processes in their respective area of specialization, including but not limited to:

  • Packaging Equipment

  • New Package Introduction

  • Combination Product and Device Packaging

  • Technical Profile Drawings to facilitate artwork layout on qualified components

  • Packaging Process and component development and optimization ensuring fit for purpose and fit for use acceptance criteria are met

• Mitigating risk to patient supply by identifying and qualifying (or supporting the qulaificaiton of)  alternate packaging components and/or sources

• Establish Packaging (technical) KPI’s in EST forum to ensure consistent, reproducible quality products are supplied to our patients

• Ensuring all Takeda PTRB, global core values and Takedisms are upheld in every task

• Author, review, and approve regulatory and technical documentation, including but not limited to CMC, SOPs, Validation Master Plans and Technical Reports.

• Author, review, & approve eQMS documents including change controls, deviations, investigations, and CAPA’s.

• Insure automation readiness.

• Foster, build and maintain strong relationships with key internal and external stakeholders

• Must be able to function independently in providing sound solutions to complex technical challenges.

What you bring to Takeda:

• Advanced degree in a scientific/technical discipline with 4-8 years’ experience .

• Experienced collaboration with highly technical cross-functional global teams.

• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred. JP, SFDA, etc. is a PLUS

• Solid organization, problem solving, project-management, decision-making, judgment, and team-oriented skills are essential.

• Demonstrated ability to simultaneously manage multiple projects of variable complexity.

• High change agility with ability to see the strategic while managing the tactical elements of global pharmaceutical product packaging.

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