Manufacturing Director jobs in Troy, NY

We are currently looking to fill a Director External Manufacturing- New Modality Operations position. In this role you will be accountable for manufacturing operations at Contract Manufacturing Organizations and partners of non-monoclonal antibody products. This is primarily focused on, but not limited to, operations for cell & gene therapy modalities and other new technology platforms. This leadership role is responsible for building and leading all aspects of an external manufacturing network to support manufacturing operations for clinical and commercial new modality products. The role will lead multiple manufacturing teams and be a key member of the External Manufacturing Leadership Team.

In this role a typical day may include the following:

• Lead all aspects of clinical and commercial new modality operations at CMOs globally

• Build and lead successful teams by hiring skilled talent

• Lead and continuously improve CMO governance processes with strategic external partners, define key meetings and agendas, establish efficient issue escalation and resolution processes, oversee CMO execution and performance, implement core and custom critical metrics that enable proactive action to emerging issues in manufacturing and supply.

• Ensure New Modality Manufacturing teams are sufficiently staffed and trained for rapid response to manufacturing events, proactively identify issues, effectively determine root cause, and implement effective CAPAs.

• Support and collaborate with the internal cross-functional teams to ensure successful technical transfers, process validations and CapEx project executions within your CMO network of responsibility.

• Ensure all external DP Manufacturing operations are completed under cGMP conditions; ensures domestic and international regulatory compliance;

• Collaborate with development organizations to implement processes developed at various scales; and collaborate to simplify new process technical transfer processes

• Support Procurement in contract and project plan negotiations.

• Be knowledgeable of the CMO market and initiatives of strategic partners. Find opportunities and risks that impact Regeneron’s commercial and clinical portfolios of medicines.

• Support the preparation and review of manufacturing sections for regulatory submissions as needed.

This role may be a fit for you if:

• Possess the ability to think strategically while being able to quickly adapt to emerging situations. This individual must enjoy being challenged to think critically and embrace new and emerging technologies being developed within R&D.

• Demonstrates leadership with expert knowledge of pharmaceutical manufacturing

• Excellent at building internal and external partnerships, efficient at identifying and removing barriers for team and projects, and effective at communicating to a wide audience of experience, skills and expertise.

• Solid understanding of clean room or classified area requirements.

• Has knowledge of technical and process transfers.

• Highly skilled and experienced in collaborating with Contract Manufacturing Organizations and strategic partners.

• Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)

• Strong interpersonal, cross- cultural, communication, negotiation and problem-solving skills qualification preferable.

• Ability to travel up to 50% (domestic and international).

Education and Experience:

To be considered for the Director level role you must have a BS/MS in a scientific field with minimum 12 years of related experience in a biopharmaceutical cGMP environment. MS/MBA preferred. 5 years management and/or leadership experience required.

To be considered for the Senior Director level role you must have a BS/MS in a scientific field with minimum 15 years of related experience in a biopharmaceutical cGMP environment. MS/MBA preferred. 10 years management and/or leadership experience required.