Industrialization Senior Specialist

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?


* Health Insurance


* Pension Plan


* Benefits


* Career growth and internal opportunities


* Production bonus


* Employee Recognition Programs

We are seeking to hire a  Industrialization Senior Specialist to join our Industrialization Team at Italian sites.

If any of the below describes you, we would love to meet you! 

Summary

Reporting directly to the Senior Manager, Industrialization - Italy, the Industrialization Senior Specialist supports industrialization department activities by providing her/his technical expertise and collaborating with relevant business units (e.g.

R&D, Manufacturing, Quality, Regulatory, Business Development) during scale-up, process validation, technology transfer, implementation of manufacturing processes and life cycle management of existing products.

This Senior Specialist works in an effective and cooperative manner under deadlines and in respects of Company policies, procedures and regulations.

Responsibilities:


* Carries out his/her work in compliance with company procedures and in accordance with the provisions of the Occupational Health and Safety Management System and Good Manufacturing Practices.


* Assesses technical feasibility, calculates cost of goods, prepares capital investments and capacity analyses of commercial products and Technology transfer opportunities.


* Collaborates with Business Support Team, Industrialization Manager and involved business units providing all the information needed to prepare commercial proposals.


* Works with Pharmaceutical Development (R&D) to scale-up and validate new products from lab to industrial scale and is accountable for industrial scale registration batches.


* Contributes to Life Cycle Management of existing commercial products, including recurrent manufacturing process validation activities, process improvement and optimization.


* Is accountable with Industrialization Team for the Manufacturing Process Validation Plan, writes protocols and reports, and provides technical assistance to Operations and Quality during the manufacturing process validation runs.


* Identifies quality improvement and cost reduction opportunities.


* Provides technical support and project management to add new sources of API, excipients, and packaging components.
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