Product Lead (Drug Product)

Summary:

A Product Lead (Drug Product) is required for a biopharmaceutical company in South Dublin. The successful candidate will be responsible for leading tech transfer projects. This is a hybrid role, that will require the incumbent to be onsite 3 days per week.

Responsibilities: Manage and develop product lifecycle management programs (multiple products). Assist in developing long term site product vision and strategy. Serve as main point of contact for global operations leads and product delivery teams. Ensure that site's needs are presented and prioritized appropriately at site and global level. Build and manage the relationship with the product and process knowledge SMEs at network and site level. Develop site product risks and implements plans to remediate risks. Make critical decisions and provide Process Transfer Technical leadership on the cross-functional Tech Transfer/NPI project team and at Technology Development and Transfer Governance Forums. Engage at site product governance meetings i.e., Product Weekly Review meeting, Site Ops meeting. Ensure changes to global product roadmap and contract books are fed back to site through Product governance and prioritized appropriately. Influence key stakeholders on site and above site and protect site strategy while meeting Network demands. Support new product/market launch. Always ensure compliance to cGMP. Ensure safety & compliance standards are maintained to the highest standards. Qualifications & Experience: Technical Degree and/or Masters' or equivalent. 5-7 years within the pharmaceutical or biotech industry and will have demonstrated program leadership skills. Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions. A working technical knowledge in a range of products and their associated manufacturing sciences, technologies and analytical processes from within parenteral fill-finish, or oral dosage forms and/or packaging. Technical or program leadership experience. Strong understanding of development, technical, manufacturing, validation, quality and regulatory processes and Product Lifecycle management. Strong understanding of current GMP regulations and industry practices & trends. Demonstrated project/programme management skills.
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