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Process Development Product Lead, Dublin
Client:
JobContax
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
af40552ec3c5
Job Views:
2
Posted:
16.03.2025
Expiry Date:
30.04.2025
Job Description:
Employment Type: Contract
Experience: 8+ years
Visa: EU passport or Stamp 4 visa required
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 gain experience in 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 organization to deliver new technologies and products to the site.
The successful candidate will have at least five years of experience within the pharmaceutical or biotech industry and will have demonstrated program leadership skills.
Responsibilities include:
1. Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions.
2. The ability to influence and lead cross-functional teams to ensure the smooth introduction of new products and the health of existing products.
3. The ability to work independently and identify risks and mitigation pathways for new and existing products.
4. A passion for continuous improvement applied to product and program leadership.
5. Act as the Product Health Steward and own product health for the products in their brief through product governance and effective product team leadership.
6. Manage and develop product lifecycle management programs (multiple products).
7. Assist in developing long-term site product vision and strategy.
8. Serve as main point of contact for global operations leads (GOLs) & product delivery teams (PDTs).
9. Ensure that site’s needs are presented and prioritized appropriately at site and global level.
10. Build and manage the relationship with the product & process knowledge SMEs at network and site level.
11. Develop site product risks and implement plans to remediate risks.
12. 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.
13. Engage at site product governance meetings, i.e., Product Weekly Review meeting, Site Ops meeting.
14. Ensure changes to global product roadmap and contract books are fed back to site through Product governance and prioritized appropriately.
15. Influence key stakeholders on site and above site and protect site strategy while meeting Network demands.
16. Support new product/market launch.
Compliance Related Tasks:
1. Always ensure compliance to cGMP.
2. Ensure safety & compliance standards are maintained to the highest standards.
3. Ensure financial compliance in line with Business & Financial guidance.
4. Support a culture of personal responsibility within reporting structure.
Requirements:
1. Technical Degree and/or Masters’ or equivalent.
2. 5-7 years in biopharma/pharma industry.
3. 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.
4. Ability to identify gaps/risks and put appropriate remediation plans in place.
5. Technical or program leadership experience.
6. A proven track record in the ability to transfer goals and objectives into measurable plans.
7. Strong process and manufacturing background.
8. Transversal working & collaborative style - must be able to work with and maintain trust at all levels of the organization.
9. Strong understanding of development, technical, manufacturing, validation, quality and regulatory processes and Product Lifecycle management.
10. Strong understanding of current GMP regulations and industry practices & trends.
11. Demonstrated project/program management skills.
12. Excellent Communication Skills – continually communicating with peers and stakeholders both internally and globally.
13. Strong interpersonal skills.
14. Strong leadership skills, especially with respect to collaboration, influencing, and coordination.
15. Customer-focused decision-making skills.
16. Ability to prioritize complex projects.
Package:
Minimum 12-month contract with the possibility of an extension.
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