Associate Director, Cmo Operations Lazio

Associate Director, Cmo Operations
Roma
Lazio, Lazio

A request:

For this role it is essential to speak both Italian and English.

However, as English is our internal business language, we ask that all CVs / resumes are submitted in English.

If a CV is not submitted in English, it will not be considered.

Thank you!

**Una richiesta:

Per questo ruolo è essenziale parlare sia italiano che inglese.

Tuttavia, poiché l'inglese è la nostra lingua commerciale interna, chiediamo che tutti i CV / curriculum siano presentati in inglese.

Se un CV non è presentato in inglese, non sarà preso in considerazione.

Grazie!

*The Role:

Reporting to the Director of International Fill and Finish Operations, this position will coordinate and drive cGMP manufacturing activities at Moderna's Drug Product Contract Manufacturing Organizations (CMO) to ensure on-time and in-full deliveries.

This includes responsibility to ensure all operational related activities at the CMOs are conducted to meet all of Moderna's requirements. Here's What You'll Do:

Lead supporting efforts at CMOs in executing operational and tactical plans.

Partner with Quality, Technical Development, Manufacturing Science and Technology (MS&T), Supply Chain, Legal, Finance and Regulatory on all aspects of the relationships with the CMOs. Responsible for ensuring that all operational related activities at the CMOs are conducted to meet Moderna's requirements (Compliance, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx). Oversee Contract Management Process with CMO.

Partner with key Procurement, Legal and Finance in the preparation and negotiation of Statements of Work (SOW), Change Orders (CO) and supportive agreements.

Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries. Maintain the integrity of the Master Supply Agreement, ensuring alignment with Quality agreements and appropriate documents. Ensure externally manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality. Approve instructions relating to external production operations and ensure their strict implementation by the CMOsEnsure in collaboration with quality that the appropriate qualification, maintenance, training and validations are performed to meet the appropriate Moderna's requirements. In collaboration with Quality and MS&T, coordinateinvestigations and troubleshooting efforts at CMOsReview and approve the appropriate GMP documentations as required e. g:

change request, deviations, master batch records, annual product quality reviews (APR/PQR), internal SOP´sDrive for and implement agreed continuous improvements at CMOs.

Lead and track life cycle projects at CMOs impacting manufacturing operations, in close collaboration Regulatory, MS&T, Supply Chain and Quality operations. Collaborate with internal cross-functional teams to understand needs/expectations for CMO performance.

Drive contract manufacturer capability and capacity to enable on-time and predictable delivery of the product. Lead periodic reviews and execution of the MPS (Master Production Schedule)Support the track and monitor of the External Manufacturing budgetFrequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with CMOs Counterparts in order to assess the as is state & risks for action-oriented improvement plans. Here's What You'll Bring to the Table:

**Education**:

Advanced degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering). 10+ years' experience in Pharmaceutical/Biotechnology Industry5+ years in managing contract manufacturing or similar business responsibility with demonstrated track record in leading cross functional team. Experience in mRNA vaccine manufacturing process or operational experience in drug product formulation, lipid nanoparticles formulation and aseptic filling are advantageous. Adapts departmental plans and priorities to address resource and operational challengesDemonstrated experience in leading cross-functional teamsAbility to work in a fluid environment and foster a strong collaborative spiritAbility to negotiate and sustain networking relationshipsSolid judgement with ability to make good decisionsGood business acumen and experience in contract negotiation are highly desirable. Experience in development of CMO KPI and monitoring adherence to KPI. Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environmentA leader who is self-reflective and leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement. Results oriented - you set a high bar for yourself and othersAbility to navigate through ambiguity and rapid growth and adapt to change. Strong proficiency in English and Italian. Travel is required up to 40%