Team Horizon

Manufacturing Team Lead (Biologics) (BB-4DF7D)

Found in: Neuvoo IE

Team Horizon currently has an exciting opening for a Manufacturing Team Lead to join our client’s brand new state of the art biologics fill-finish facility in Sligo.As the Manufacturing Team Lead, you will guide and support a team of skilled Biologics Technicians across filling, lyophilization, equipment preparation, formulation, buffer preparation and processing activities in the biologics fill-finish facility to meet clearly stated operating objectives.Why you should apply: * Join a company that has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work. * Generous package with good base salary and benefits to including but not limited to health insurance, pension and bonus. * Join an organisation who uses Innovative new technologies, who embrace diversity, equality and inclusion and puts patients first. * Based in the West of Ireland the cost of living is low, meaning more disposable income. * Upgrade your work-life balance, the quality of life is amazing, less traffic more time for activities!What you will be doing: * Manage, motivate and develop the manufacturing team and provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls * Instil a culture of contamination control and compliance with aseptic best practice * Deliver daily reporting on the status of all operations and support activities * Manage verification and updating of manufacturing control system transactions accurately and in a timely fashion * Act as a key point of technical contact for aseptic fill-finish activities including communicating departmental goals to biologics technicians and providing cost-effective quality compliant products in a safe, effective manner * Liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing * Resolve operations/project issues by working with team members, project customers, and others as appropriate * Promote operations excellences culture and Key operations targets including OEE where applicable * Provide direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits * Ensure the execution of fill-finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives * Ensure successfully review, amendment and implementation of changes to SOPs * Promote a culture of Right First Time, Behavioral Based Safety, Always Audit Ready and Human Error Reduction within their team * Develop direct reports by securing appropriate training, assigning progressively challenging tasks, and managing mid-year and annual reviews * Schedule human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget * Provide required technical guidance and approval for manufacturing batch record * Compile data from manufacturing, performing statistical analysis to trend and track process performance * Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activitiesWhat you need to apply: * Degree qualified (masters/PHD preferred) in Process, Biopharmaceutical, Chemical Engineering, or other relevant discipline required * A minimum of 5 years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry A minimum of 1-year team direct supervisory experience essential * Detailed knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required for this role * Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing * Technical knowledge of Biologics/Aseptic Fill-Finish manufacturing process * Experience of start-ups and/or new product introductions to biopharmaceutical/pharmaceutical facilities (Biologics Preferred). Must be able to lead & project manage these activities * Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements. * Possess a strong technical knowledge and application of concepts, practices, and procedures. Experience in working on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercise judgment and advises management as to the appropriate actions

calendar_today19 hours ago

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