We are looking for a candidate with a consolidated experience in pharmaceutical processes and GMP. As Senior Process Specialist you will join a project in a leading pharmaceutical company working based on their Manufacturing Site in Italy.
Global MSAT will lead the Scientific Process Ownership securing reliable and cost competitive supply of pharmaceutical products to our patients. As being Scientific Process Owners our client understands the processes of strategic products on a scientific level and act proactively according to data. MSAT will mainly focus for the next 1-2 years in the introduction of new API suppliers in their corresponding finished products.
- Be responsible for the design and performance of laboratory scale and pilot scale trials.
- Prepare protocols/reports for lab scale, pilot scale and commercial scale trials.
- Provide process and technical support to Business Units as Subject Matter Expert within FGM.
- Review documentation relating to production and regulatory registrations.
- Evaluate proposed changes to processes, raw materials (excipients, APIs, packaging) and equipment.
- Lead problem solving and process related investigations.
- Be Technical lead of transfer teams.
- Train personnel in process developments and process related procedures.
- Ensure that processes are in a validated state and process monitoring is performed effectively.
- Master’s degree and preferably a PhD in pharmacy, chemistry or related discipline.
- Fluent Level of Italian and English.
- At least 3 years’ experience from the pharmaceutical or chemical industries. Preferably in Finished Goods Manufacturing, CMC development and/or process validation functions.
- Experiences within R&D and GMP production and a holistic finished product and formulation knowledge from a FGM production site.