Senior Manager Manufacturing Process Development

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A global biopharmaceutical company focused on the treatment of weight loss are seeking a Senior Manager Manufacturing Process development for their Dublin city centre office. This is an exciting opportunity to be part of a changing organisation and you will be at the forefront of new developments.

The Senior Manager Manufacturing Process Development will oversee process development, scale up and improvements to commercial processes for solid oral dosage products at contract service providers.

Being an internal process expert that establishes metrics, analyzes data and makes recommendations to the management team. You may lead project teams responsible for manufacturing development, material and equipment qualification, and investigations of process variances.

Responsibilities:

* Provide oversight at manufacturing sites for process changes

* Author technical reports documenting process improvements

* Define and maintain a database of manufacturing data that supports the life-cycle of a product from development through late-stage commercialization

* Reviews and approves validation and production documents, including protocols, development reports and batch documentation

* Resolves deviations and CAPAs related to manufacturing operations

* Ensures quality and regulatory compliance include, authors drug product CMC sections for regulatory filing

Job Requirements:

* A minimum of a Bachelor of Science degree in Engineering, Pharmacy or a related discipline.

* A minimum of 8 years relevant experience in pharmaceutical development or operations including at least 3 years of solid dosage manufacturing.

* Experience in late-stage solids dosage process development, technology transfer and commercial manufacturing technical support.

Ability to travel domestically and internationally (up to 30% of time)

Company Culture:

You will be joining a team that is passionate about making a difference in people's lives. It is a fast-paced environment emphasizes innovation and achievement. Commitment to patients is central in their work every day helping them achieve their common goal of improving patients' lives. This company offers exciting challenges and unique opportunities for career growth in a collaborative, open and fun environment.

If interested please send your CV for review.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales