Sapes, East Macedonia and Thrace, Greece
82 days ago
Process Development Expert

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.

Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to attract a Process Development Expert for the Innovative Formulations department to be based at our Sapes premises and interact remotely with Formulation team based at RnD Metamorfosi site.

 

As a Process Development Expert you will be responsible for the design of process transfer from small to industrial scale and participate in the establishment of custom made industrial equipment/facilities.

More particularly:

What you’ll do:

Design the process transfer from small to industrial scale in collaboration with the R&D teams  Supervise the execution of the process transfer trials Develop process flow diagrams and in process control strategies Prepare process transfer plans and protocols Review and approve process transfer batch records and reports Support the manufacturing of the process validation batches Review process validation protocols and reports Contribute to the development of batch manufacturing master documents Assess batch manufacturing data, participate in manufacturing investigation and recommend process improvements Contribute to the design of custom equipment/facilities (manufacturing skids and filling lines) and the preparation of the URS based of the development plan Monitor the construction of the custom equipment/facilities and respond for process related aspects Contribute to FAT, SAT, IQ/OQ of new equipment/facilities Prepare and/or review Qualification protocols and reports Train production staff and new team members on the new processes Follow the GMP and Quality standards of the manufacturing site Participate in professional development activities/seminars to keep updated to latest technologies and developments in the field.
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