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Product Lead – Process Development

Amgen Dun Laoghaire – Dublin

Overview:

The Product lead – Process Development will report to the Sr. Manager Process Development in the Portfolio Management and Delivery group and will be responsible for leading a cross-functional product team in a matrix organisation to deliver new technologies and products to Amgen Dun Laoghaire. The successful candidate will have at least five years experience within the pharmaceutical or biotech industry and will have demonstrated program leadership skills.

The ideal candidate will have:

• Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions

• The ability to influence and lead cross functional teams to deliver to ensure the smooth introduction of new products and the health of existing products

• The ability to work independently and identify risks and mitigation pathways for new and existing products

• A passion for continuous improvement applied to product and program leadership

Scope of Role:

• 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

Compliance Related Tasks:

• 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

Skills & Knowledge:

• Transversal working & collaborative style - must be able to work with and maintain trust at all levels of the organization

• 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

• Excellent Communication Skills – continually communicating with peers and to stakeholders both internally and globally.

• Strong interpersonal skills

• Strong leadership skills, especially with respect to collaboration, influencing and co-ordination

• Customer-focused decision-making skills.

• Ability to prioritize complex projects

Qualifications:

• Technical Degree and/or Masters’ or equivalent

Experience:

• 5-7 years in biopharma/pharma industry

• 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

• Ability to identify gaps/risks and put appropriate remediation plans in place

• Technical or program leadership experience

• A proven track record in the ability to transfer goals and objectives into measurable plans Strong process and manufacturing background