External Manufacturing and Supply Specialty Care Large Molecules, Principal Operations Lead

External Manufacturing and Supply Specialty Care Large Molecule oversees drug substance, drug product, and finished goods manufacturing operations at our Contract Manufacturing Organizations (CMOs). As the main point of contact between Sanofi and our CMOs, you will ensure successful execution of manufacturing projects, foster strong relationships, and drive value to meet business objectives.

Position Overview with Key Responsibilities

Specialty Care Large Molecule Operations will work in partnership: 

• With External Manufacturing Product Teams (EMPT) members, EM&S business partners and CMO partners 

• Responsible for on time and in full delivery of products for CMOs/External Suppliers within EMPT unit, accountable for tracking of EMPT KPIs. Drives continuous improvement in the performance of the supplier in areas of Safety, Quality, Cost & Delivery 

• Responsible for all EMPT CMO operational activities including input into contract development and lifecycle management, CMO performance review and monitoring, CMO project oversight, Periodic Business Review and participation in site visits. 

• Responsible for on time delivery of Quality System related records. Participates in cross-functional team investigations into major and critical deviations. 

• Supports the EMPT products/CMOs from a financial perspective through the management of related activities against contract guidelines (MSA & QTA) including issuance of purchase orders, adherence to non-COGs budget.

• Responsible to ensure identification, evaluation, and documentation of risks potentially impacting quality and compliance. Participates in multi-disciplinary teams to define remediation plans to mitigate risks impacting products and GxP Operations.

• Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (GSC, MSAT, Legal etc). Coordinating team activities with EMPT Quality and Supply Chain team members to ensure full alignment within the EMPT. 

• Responsible for the successful project execution of Sanofi Tier 3 projects and CMO projects directly related to EMPT products.

• Responsible for other activities, as needed

Leadership Qualifications

N/A

Basic Qualifications

Experience: 

• Bachelor’s degree with scientific background or equivalent and 5+ years of experience or Experience in operational roles, ideally as Site manager, SLT member 

• Good functional knowledge of industrial business processes 

• Good exposure to cross sites & cross GBUs networking is a plus. 

Technical skills 

• Basic or good understanding of data management and IA digital products 

• Knowledgeable in E2E product & industrial strategy, performance management, project management and biotech/pharmaceutical industry technologies 

• Strong analytical skills. 

• Good command of KPI target setting & monitoring 

• Languages: Fluent English

Preferred Qualifications

Experience: 

• Bachelor’s degree with scientific background or equivalent and 5+ years of experience o Experience in operational roles, ideally as Site manager, SLT member 

• Good functional knowledge of industrial business processes 

• Good exposure to cross sites & cross GBUs networking is a plus. 

• Master’s degree with scientific background or equivalent and 4+ years of experience 

Skills: 

• Basic or good understanding of data management and IA digital products 

• Knowledgeable in E2E product & industrial strategy, performance management, project management 

• Knowledgeable in biotech/pharmaceutical industry technologies 

• Strong analytical skills. 

• Good command of KPI target setting & monitoring 

• Languages: Fluent English

Special Working Conditions

Up to 20% Domestic or international travel