Process Development Product Lead - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based
Pay: €55 - €65 per hour
Experience: 8+ years
Visa: EU passport or Stamp 4 visa required
Process Development Product Lead - Dun Laoghaire, Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
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 site.
The successful candidate will have at least five years experience 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
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
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
Requirements
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
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
Package
Contract role - Hourly rate €55 - €65 per hour
Minimum 12 month contract with the possibility of an extension.