Job Description

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
  

Requirements

Qualifications/Experience

•               Technical Degree
and/or Masters’ or equivalent

•               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