Manufacturing Business Unit Leader
Job ID : 91507BRLocation : United Kingdom - Swindon : Job DescriptionWhen you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.Position Summary:The Business Unit Leader will be responsible for leading a Condo, a fully serviced, highly customized cGMP facility with onsite client presence. The BU Leader will work alongside all departments to ensure the Condo RFT, Quality and Delivery targets are met. The BU Leader will drive the department stakeholders to manufacture, fill, inspect and pack drug products, safely in line with the companies EHS regulations, in accordance to company quality regulations, and external regulatory compliance. Responsibilities:Leadership/ People Management: Optimize performance outcomes of the Condo by providing leadership and direction to the Condo team. Acts as role model for Patheon leadership capabilities and sets the standard to follow.Lead a matrix organization to ensure cross functional alignment and alignment on priorities for the Condo.Drive headcount planning for current and future Condo needs. Take a site wide view regarding capacity and flex resources accordinglyMaintain an accurate Training Matrix and ensure Performance Management and Development Plans are in place for all team members, including both job technical knowledge and pharmaceutical knowledge development.Support the Production Manager and deputise in their absence.Issue resolution plans utilising Production, Quality and Maintenance resource allocated to the production area with no impact to the schedule.Track and monitor operational metrics, including downtime, and implement strategies to reduce downtimeCommercial Leadership: Work in close partnership with the client to deliver strategic and tactical plans.Present, summarise and follow through on strategic and tactical plansParticipate in quarterly business review and steering committee meetingsEnsure regular communication with the onsite Client and off-site contacts.Deliver revenue and commercial targets and take responsibility for the department budget.GMP/ Compliance and Ethical Conduct: Ensure compliance of self and others to internal and external regulations. Comply with all systems, processes and procedures in line with statutory/ legislative/ quality requirements.Support and encourage a Quailty CultureDeliver a timely closure of BMRs as agreed with the department manager (including all MRP transactions).Investigate and lead process related deviations to ensure manufacturing, filling and packaging activities are compliant with cGMP. Drive timely completion of DRs, CAPAs, and CCs as agreed with the department manager.Drive effective corrective and preventative actions for GMP incidents, troubleshooting situations. Identify staff training and development needs to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives. Ensure your area is audit ready at all times.Through a presence in the workplace, coach and mentor staff to ensure products are manufactured and documentation completed in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements. Timely completion of relevant deviation and complaint investigations to identify true root cause. Along with timely closure of corrective/preventative actions for deviations, complaints and GMP audits that are assigned to them with a focus on improved processes, documentation, documentation completion and training.To ensure work centre and designated areas housekeeping standards are maintained to ensure compliance with Current Good Manufacturing Practice (cGMP) and Health Safety & Environment regulatory requirements by utilizing 5S and lean initiativesCompletion of Level 1 & 2 audits.Maintain a high level of tidiness and cleanliness at all times – personal, personnel, work area and department. Ensure aseptic licences, as required, are kept up to date for all personnel involved in sterile manufacturing.Lean & Change Management: Ensure all work is performed and delivered in accordance to approved and established processes and procedures and proactively look for opportunities to drive continuous improvement, influence decisions and deliver the results whilst ensuring an appropriate level of compliance. Agree measures of performance and targets and communicate to the teams through the daily communication processes (handovers, huddles and VMBs) to achieve targets. Monitor and report team performance to targets using VMBs Tools.Develop VMB tools for the area to improve and track KPIs as follows:Deliver 100% Schedule AdherenceDeliver 100% RFT BMR to QA within 24hoursDeliver OTIF closure rate of all quality actionsZero Critical audit observationsZero overdue, CAPAs, DRs, EHS and CCsZero overdue EHS actions Responsible for initiating, developing and implementing strategic development programmes relating to improvements and advancement in manufacture, filling, inspection and packing.Support the implementation of continuous improvement programmes and the introduction of new products, equipment and processes.Safety, Health & Environment: Promote an environment of safety and wellbeing of self, others and environment.Understand and ensure implementation of emergency procedures and safe systems of work.Ensure compliance with environment, health and safety rules, signage and instructions at all times.Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.Working alongside the EHS Manager and conduct scheduled audits.Minimum Requirements/Qualifications: Experience of manufacturing sterile drug products to EU and US standards.Leadership experience in a Pharmaceutical environment (Manufacturing, Packaging/ Quality, Engineering or equivalent). Experience of startup facility activities desirable, good knowledge of facility validation requirements.Experience of medium to large scale pharmaceutical manufacturing, desirable powder manufacturing.Experience of working with clients would be an advantage Preferably qualified to degree level in Science, Business or Engineering or equivalents.Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.Experienced in managing and leading change, continuous improvements.Understanding of the end to end pharmaceutical manufacturing process essential.Demonstrable ability to make sound risk based decisions in line with internal and external quality standards.Able to lead in matrix organisationsStrong drive for resultsStrong experience in lean manufacturing techniques.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.