Clinical Trial Manufacturing Scientist

3 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

In this role you will lead client’s projects from a technical standpoint, developing the optimal manufacturing process, defining the equipment needed, and configuring manufacturing equipment to meet production requirements. We will support your growth and and ability to work indipendently to make the difference for our elite clients

A hands-on, dedicated approach to problem solving will be key in exceeding client’s expectations, and the ability to “think out of the box”, coupled with a strong technical experience, will help you in troubleshooting and finding new solutions to problems.

**Responsibilities**:

- As the technical owner of the project, you will oversee the Technology Transfer Process, defining the materials to be used during the manufacturing of liquid and lyophilized products and the manufacturing process flow.
- Act as the main point of contact with internal and external customers, handling the approval process.
- Prepare the technical documentation required by internal SOP such as Master Batch Record
- Participate to clinical/commercial batches manufacturing inside PDS sterile suite.
- Update the clients about the state of the project, proactively anticipating issue and ensure a timely management of technical problems

**How will you get there?**

**Required Skills and Experience**:

- Degree in Chemistry/ CTF/ Biological Sciences or similar fields
- At least 2 years of experience in pharmaceutical R&D, in engineering, manufacturing or quality units with liquid and lyophilized sterile injectables
- Experience with drugs formulation and aseptic manufacturing process
- Experience in drafting GMP documentation such as MRBs (Master Batch Record)
- Strong communication and team-working skills
- Ability to organize and handle multiple projects and activities in a highly dynamic environment
- Fluent English and Italian

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