Sr. Specialist, Ms&T - Person In Plant Monza

Sr. Specialist, Ms&T - Person In Plant
Monza
Lombardia, Monza

The Role**:

Reporting to the Director, International Fill Finish, the International Fill Finish Senior Specialist is a newly created position and will have the opportunity to collaborate in the definition and buildup of the External Manufacturing Fill Finish function in Italy for Moderna.

The International Fill Finish Senior Specialist will liaise with Moderna's International Fill Finish Contract Manufacturing Organizations (CMOs) to ensure on-time and in-full deliveries.

This includes supporting the Director, International Fill Finish Operations to ensure all operational related activities at the Fill Finish CMOs are conducted to meet all of Moderna's requirements.

This role will collaborate with other functions locally and in the US to continue to execute on Moderna's production strategy.

**Here's What You'll Do**:

- Support the Director, International Fill Finish Operations in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs).

- Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries.

Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.

- Ensure operational related activities at the FF CMOs are conducted to meet Moderna's requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).

- Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.

- Ensure that instructions relating to external production operations are strictly implemented by the CMOs

- Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna requirements.

- Support and perform the reviews for process performance at FF CMOs.

- Monitor Key Performance Indicators of FF CMOs.

- Support preparation of periodic business and operations review meetings.

- Drive for and implement agreed continuous improvements at FF CMOs.

- Coordinate reviews and approvals of various documentations from FF CMOs.

- In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOs

- Write or revise the appropriate GMP documentations.

- Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans.

- Performs other administrative duties as required.

**Here's What You'll Bring to the Table**:

- Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master's Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred

- Fluency in English and Italian are required

- Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment

- Ability to work with members of partner organizations (CMOs)

- Well organized - a natural ability to be organized in how you think, communicate and conduct your work

- You drive for results - you set a high bar for yourself and others

- Good critical thinker that can anticipate the needed next step and therefore can work independently

- A curious mindset that allows you to constantly learn and challenge the status quo

- Ability to navigate through ambiguity and rapid growth and adapt to change.

**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 winter break

- 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

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

Moderna maintains alliances with a broad range of