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Job Description

About the role:

You will be in charge of managing relationships with global CMOs that produce a range of packaged finished OESSM products.

This role entails both strategic oversight of segmented and transactional CMO partnerships and hands-on management.

In addition, you will define the acceptance criteria for these products, ensuring they adhere to regulatory standards and meet the practical needs of end-users for functionality and purpose.

How you will contribute:

• You will manage CMO’s systems and packaging procedures to align with Takeda acceptance criteria.

• Package Tech Transfer, Product Launch and Continuous Improvement project management skills  required in managing transfers between CMO’s and internal sites.

• You will participate to the design and implementation of harmonized packaging solutions leveraging automated inspection systems reducing opportunities for human error and patient complaints.

• You will manage packaging deviations/investigations and trends for assigned products @ packaging CMO.

• Will write, update, and implement new, improved quality standards, procedures, and job aids.

• Leverage automation to achieve continuous improvement/factory of the future.

• You will implement and deliver packaging improvements with stakeholder buy-in.

• Defining and mitigating risk of supply disruptions.

• You will provide technical oversight of existing packaging production, technology, methods, procedures, and specifications to ensure effective ongoing production and process improvements at CMO

What you bring to Takeda:

• You hold a Degree in Engineering: Packaging/Mechanical/Industrial or Electrical Engineering

• Experience (minimum 8 yrs) in Technical GMP pharmaceutical packaging operations.

• Knowledge of Global Market Regulatory requirements for finished drug product  of pharmaceutical products to optimize packaging.

• Expertise in pharmaceutical packaging operations, including the latest industry practices, and product packaging tech transfers.

• You are a forward-thinking professional in packaging technology, emphasizing designs that ensure product integrity and enhance stability.

• Proficient technical written and oral communication skills

• Knowledge of end to end drug product manufacturing processes for OSD/SOD, parenterals including vials, PFS, BFS, and combination products.

• You have CMO/Site operations lead experience.

• Experienced in product Launch, Market Expansion, Continuous Improvement, and Supply Chain Integrity (including serialization, aggregation and EUFMD)

• You are proficient knowledge of global regulatory regulations relating to product packaging (primary and secondary).

• You have demonstrated leadership through actions and influence, upholding integrity and demonstrating perseverance in achieving objectives.

• Broad influence spectrum, engaging with global Packaging Engineering teams and key stakeholders, ranging from Senior Executives to site-level Packaging Operators across diverse Contract Manufacturing Organizations.

• Strong track record of strategic decision-making, integrating both quantitative data and qualitative judgement.

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