Associate Director External Manufacturing

Job Summary (Primary function)

This position is within the Global Biologics External Manufacturing in the Technical Operation Department. The position will play a leading role in the management of the third parties (CMOs) and will be part of a team focused of successful launches, commercialization and life cycle management of the Biologics portfolio

The position supports all activities occurring at CMOs related to contract agreements and manufacturing, which can include but is not limited to, project management, document readiness, coordination of internal manufacturing teams, batch release support, investigations, validation activities, and budget management.

**DUTIES AND RESPONSABILITIES**
- Manage CMOs to ensure clarity and attainment of milestones and timelines; develop mitigation plans as needed to achieve project deliverables.
- Organize and lead CMO Annual/Operational Business Reviews
- Identify issues and facilitate problem solving, contingency planning, and decision-making.
- Coordinate with Incyte Supply Chain to secure manufacturing capacity and maintain manufacturing timelines to avoid stock out
- Support Manufacturing investigations with Quality Assurance
- Inform key stakeholders of project status, and existing or potential issues and propose solutions as appropriate
- Review and assess agreements from technical & management point of view
- Manage deviations and change controls in Veeva
- Work closely with supply chain to ensure the launch readiness
- Single point of contact for the CMOs
- In collaboration with supply chain, develop an inventory strategy to ensure product supply to all markets
- Accountable for converting demand planning forecast into production / inventory requirement for external suppliers
- Review and assess RFPs, Contracts and Statement of Works from technical & management point of view
- Establish, manage and oversee all aspects of the relationship with Biologics co-manufacturing partners
- Manage and track POs and budgets
- Contribute to product cost reduction initiatives
- Lead the negotiations and subsequent maintenance of the contractual pricing and content on new and contract renewals
- Work effectively in a matrix organization
- Manage and/or create internal documents and SOP’s to ensure cGMP compliance
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines
- Delegate to: Global Biologics Commercial Manufacturing

**REQUIREMENTS**
- Bachelor’s degree required; MBA or advanced degree preferred
- 10 yrs of Experience in Biotech manufacturing of drug substance and aseptic fill and finish
- Experience in Project/Program management in life sciences organizations
- Understanding of supply chain management principles such as Production Planning, Purchasing, Forecasting and Logistics
- Experience in contract agreement with Drug product and or Drug substance contract manufacturer
- English fluency written and spoken, French is a plus
- Excellent communication skills
- Natural problem solver and negotiator
- Strong analytical, organizational and execution skills
- Ability to work both independently and as part of a team is essential
- Excellent written and verbal skills
- Travel required

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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