Sr. Specialist Ms&t

5 mesi fa

Roma, Italia Moderna A tempo pieno

**The Role**:
This role in the Manufacturing Science and Technology (MST) department to support Moderna’s Contract Manufacturing Organization (CMO) activities in Europe.
Reporting to the Senior Manager MS&T, you will be part of Moderna’s Manufacturing Science and Technology team responsible for technical support of Moderna cGMP manufacturing activities at ROVI, Madrid.

The individual will work closely within MS&T peers, Quality, Operations and Process Development, to ensure all aspects of manufacturing are successfully executed and continuously maintained. The individual will support tech transfer, process validation activities and life cycle CMC activities, including protocol generation, oversight of CMO execution and summary report generation.

**Here’s What You’ll Do**:
Participate in technology transfer of Moderna processes into CMOs operations.

Manage and document process and project information with a robust documentation package.

Review and approve validation protocols and summary reports to ensure successful validation of Moderna manufacturing processes at CMOs. Review

Be the point of contact for manufacturing issues requiring technical investigations. Identify root cause. Coordinate and resolve issues with effective CAPAs

Manage and regularly review manufacturing data from CMO activities. Identify and investigate trends.

Manage change as part of a Global Change Control forum

Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.

Represent MS&T in audits.

**Here’s What You’ll Bring to the Table**:
M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)

A minimum of 4-6 years related work experience

Direct experience providing technical support of cGMP manufacturing operations in biologics manufacturing or parenteral drug product manufacturing. Experience to include technology transfer, investigations, and change management.

Experience in working with CMOs; and supporting commercial cGMP manufacturing processes.

Experience using statistical process control and process analytics for monitoring and improving control of processes.

Demonstrated capability of working cross functionally in a technical area outside of core expertise.

Outstanding communication skills (verbal and written) in English and Italien

Ability to manage projects in a fast-paced environment.

Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

Ability to adapt to new and challenging technical opportunities.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status

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