Summary:
A Process Development Manager (Product Lead) is required for a biopharmaceutical company in South Dublin. The successful candidate will be responsible for leading a cross-functional product team to deliver new technologies and products.
Responsibilities: Act as the Product Health Steward and own product health for the products in their brief through product governance and effective product team leadership. 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 (GOLs) & product delivery teams (PDTs). Ensure that site's needs are presented and prioritized appropriately at site and global level. Build and manage the relationship with the product & 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. Ensure financial compliance in line with Business & Financial guidance. Support a culture of personal responsibility within reporting structure. 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. 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. A proven track record in the ability to transfer goals and objectives into measurable plans. 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. Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions.
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