Job DescriptionAbout PSC Biotech
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting.
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 organization to deliver new technologies and products. The successful candidate will have at least five years' experience within the pharmaceutical or biotech industry and will have demonstrated program leadership skills.
RequirementsThe 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 functionsThe ability to influence and lead cross-functional teams 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 leadershipScope 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 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 implement 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 cGMPEnsure safety & compliance standards are maintained to the highest standardsEnsure financial compliance in line with Business & Financial guidanceSupport a culture of personal responsibility within reporting structureSkills & Knowledge: Transversal 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 skillsStrong leadership skills, especially with respect to collaboration, influencing, and coordinationCustomer-focused decision-making skills.Ability to prioritize complex projectsQualifications: Technical Degree and/or Masters' or equivalentExperience: 5-7 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 background
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