Associate Director/ Director External Manufacturing - Morges, Schweiz - Incyte Corporation

Incyte Corporation

Geprüftes Unternehmen

Morges, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

SUMMARY
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 decisionmaking.
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 comanufacturing 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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You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

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By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).