Process Development Specialist

Pharmathen

Αθήνα
Μόνιμη
Πλήρης Απασχόληση

Πριν 23 ημέρες
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Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a Process Development Specialist to join the Innovative Formulations team at Pharmathen’s Metamorfosi premises.As a Process Development Specialist, the ideal candidate will be accountable for the design of process transfer from small to industrial scale and participate in the establishment of custom made industrial equipment/facilities.RequirementsMore particularly:What you will 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 and recommend process improvements
Contributes to the design of custom equipment/facilities (manufacturing skids and filling lines) and the preparation of the URS
Monitor the construction of the custom equipment/facilities and respond for process related aspects
Contribute to FAT, SAT, IQ/OQ of new equipment/facilities
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.
Travel periodically to the manufacturing site at Sapes to support the execution of large scale activities

The ideal candidate should have:

BSc Degree in Chemical Engineering or relevant field
3-5 years experience in process development or process engineering in the pharmaceutical industry
Hands-on experience with manufacturing processes (microspheres, suspensions, gels)
Working knowledge of GMP regulations and ICH guidelines
Experience with industrial equipment qualification
Hands-on experience with the qualification of new equipment
Familiarity with SAP system
QA background will be considered an asset

Job-Specific Skills:

Excellent communication in English language (writing & speaking)
Computer literacy
Troubleshooting skills
Demonstrated ability to work on multiple projects and meet timelines

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Pharmathen