Process Development Lead

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.