Leader of Commercial Drug Product Manufacturing
6 days ago
We are seeking a highly skilled professional to lead our commercial drug product manufacturing operations in Cork, Ireland.
This leadership role is accountable for advancing our commercial product portfolio for international markets. As the leader of our Manufacturing Operations, this position will oversee stage commercialization, manufacturing, test and release of our products for international markets.
Responsibilities include providing strategic direction to the Manufacturing Operations organization, building and maintaining a site culture consistent with our values, developing and managing departmental objectives, and ensuring compliance with statutory practices.
Key Responsibilities:- Lead the cross-functional Manufacturing Operations Leadership team in the development of medium and long-term strategic plans and execute operational plans.
- Provide strategic direction and guidance to the Manufacturing Operations organization.
- Hire, mentor, and develop team members within the organization.
- Set performance goals and hold employees accountable for their performance.
The ideal candidate will have a degree in Business or Science and minimum 14 years of relevant experience in related field. Alternately, an advanced degree and minimum 12 years of relevant experience.
Requirements:- Experience leading commercial drug product manufacturing operations consisting of representatives from multiple functions such as solid oral dose manufacturing and packaging, supply chain, logistics and distribution, Formulation/Drug Product Process Development, and Analytical Operations including Quality Control.
- Experience supporting multiple regulatory filings and supporting product-related inspections for regulatory agencies, with special emphasis on the US, EU, Japanese agencies.
- Experience developing, implementing and executing strategic plans and objectives for organizations and departments.
- Experience working with external manufacturing and testing organizations.
- In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics.
Gilead Core Values: Integrity, Inclusion, Teamwork, Excellence, Accountability, Equal Employment Opportunity.
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