Process Development Product Lead - Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site BasedPay: €55 - €65 per hourExperience: 8+ years Visa: EU passport or Stamp 4 visa requiredProcess Development Product Lead - Dun Laoghaire, DublinOur 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 functionsThe ability to influence and lead cross functional teams to deliver to ensure the smooth introduction of new products and the health of existing productsThe ability to work independently and identify risks and mitigation pathways for new and existing productsA passion for continuous improvement applied to product and program leadershipAct as the Product Health Steward and own product health for the products in their brief through product governance and effective product team leadershipManage and develop product lifecycle management programs (multiple products)Assist in developing long term site product vision and strategyServe 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 levelBuild and manage the relationship with the product & process knowledge SMEs at network and site levelDevelop site product risks and implements plans to remediate risksMake critical decisions and provide Process Transfer Technical Leadership on the cross-functional Tech Transfer/NPI project team and at Technology Development and Transfer Governance ForumsEngage at site product governance meetings i.e., Product Weekly Review meeting, Site Ops meetingEnsure changes to global product roadmap and contract books are fed back to site through Product governance and prioritized appropriatelyInfluence key stakeholders on site and above site and protect site strategy while meeting Network demandsSupport new product/market launchCompliance Related Tasks:Always ensure compliance to cGMP Ensure safety & compliance standards are maintained to the highest standardsEnsure financial compliance in line with Business & Financial guidanceSupport a culture of personal responsibility within reporting structureRequirementsTechnical Degree and/or Masters' or equivalent5-7 years in biopharma/pharma industryA 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 packagingAbility to identify gaps/risks and put appropriate remediation plans in placeTechnical or program leadership experienceA proven track record in the ability to transfer goals and objectives into measurable plansStrong process and manufacturing backgroundTransversal working & collaborative style - must be able to work with and maintain trust at all levels of the organizationStrong understanding of development, technical, manufacturing, validation, quality and regulatory processes and Product Lifecycle managementStrong understanding of current GMP regulations and industry practices & trendsDemonstrated project/programme management skillsExcellent 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-ordinationCustomer-focused decision-making skills.Ability to prioritize complex projectsPackageContract role - Hourly rate €55 - €65 per hourMinimum 12 month contract with the possibility of an extension.