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Senior director of pharmaceutical process development

Cork
beBee Careers
Biostatistician
Posted: 15 June
Offer description

Leadership Opportunity in Process Development

An experienced leader is sought after to be a key member of the Site Leadership Team. The successful candidate will support the GM and SLT in all aspects of the operation and strategic planning.

The role involves owning process and analytical development activities within the business, ensuring the process is suitable for manufacture at various stages of development or product lifecycle.

The ideal candidate combines knowledge of scientific and business issues to enable products that meet required legislation.

Key responsibilities include:

* Strategic leadership and clear vision for the group, embracing change and continuous improvement while motivating and developing the team.
* Interface with customers during development and technology transfer phases, including technology and analytical transfers of products.
* Process development of products to ensure suitability for manufacture at various stages.
* Analytical development of methods for testing raw materials, intermediates, and APIs as necessary.
* Process validation of new products and lifecycle changes, including control strategy generation and validation.
* Transfer of products to Operations post-commercial validation, ensuring fit for commercial manufacture.
* Transfer of methods to QC for testing raw materials, intermediates, and API at all phases of the product lifecycle.
* Ensure safety basis is in place for all products, including appropriate safety testing.
* Material science characterization support and crystallization support.
* Technical and analytical troubleshooting and improvements.
* Stay up-to-date with current technologies and manufacturing trends.
* Develop a robust succession plan for key roles.
* Maintain a strong quality, EHS, PPI, and compliance culture across the team.

Candidate Requirements

* Minimum Chemistry or Chemical Engineering degree; M.Eng or Ph.D. preferred.
* A decisive leader who can empower teams and communicate goals clearly.
* A visionary leader who embraces continuous improvement and transformational change.
* Extensive experience in Pharmaceuticals, API manufacturing, BioPharma, or similar industries.
* Working knowledge of CDMO advantageous.
* Experience in technology transfer and process development.
* Practical knowledge leading multi-disciplinary teams at a Senior level.
* Experience in budget management.

Additional Considerations

* The ideal candidate should possess excellent communication and leadership skills.
* Prior experience in a similar role or industry is highly desirable.

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