Sterile Manufacturing Manger

Sterile Manufacturing ManagerUpperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.We are entering an exciting phase of growth with the development of our new 7,000 sq. ft. state-of-the-art sterile manufacturing facility, designed and built in full alignment with the latest EU GMP Annex 1 (2023) requirements.To support this new facility, we are looking for a Sterile Manufacturing Manager who will be responsible for all sterile GMP manufacturing operations, including process development, clinical batch manufacture, technical transfer activities and process scale up.Main duties and responsibilities:Ensure that all manufacturing operations within the Sterile GMP facility are fully compliant with the regulatory requirements set out in EU GMP Annex 1: Manufacture of Sterile Medicinal products.Ensure that all manufacturing operations within the Sterile GMP facility are fully compliant with the Upperton Quality SystemFacilitate the development and qualification of all processes and systems relevant to Sterile operations within Upperton.Lead facility tours for client visits / audits and regulatory inspections.Responsible for implementation of the Upperton Quality system in the Sterile GMP facilityEnsuring that all activities and outputs meet the Upperton quality systemDirect all scale up and production activities to ensure that project deliverables and targets are successfully met and are of the highest quality.Manage and develop the Sterile GMP manufacturing team and be responsible for their performance, training and regular appraisalResponsible for the Sterile GMP facility (including environmental controls), equipment and all process qualification / validation / simulation.Ensure that all documentation emanating from the GMP facility meets the requirement of the Upperton Quality system including operating records, batch manufacturing records and project reportsParticipate in customer contacts and business planning with the Director of Clinical Manufacturing.Track project activities from a commercial perspective. Ensure that commercial deliverables are tracked and fully met.Liaise with Project Management and Finance to ensure that correct invoices are sent out on timeProvide critical support and focus on Sterile projects, focusing on technical transfer and process scale up activities conducted both internally at Upperton and for projects outsourced to third party vendors.Essential skills and experience:Proven leadership and management skills with the ability to optimise team performance and developmentExcellent relationship management skills with the ability to engage, negotiate and manage key stakeholders across internal departmentsExcellent communication, interpersonal and influencing skillsExcellent analytical and problem-solving abilitiesResults orientated with ability to plan and deliver against project deadlinesCommercially and financially astute with experience of managing budgetsResilient, self-motivated and able to work well under pressureTechnical mindsetAn appreciation of and an ability to positively resolve issuesEssential experience required:Educated to degree level or equivalent in a relevant science / engineering /manufacturing discipline.Demonstrable experience of developing and leading a manufacturing function with a proven track record within a sterile manufacturing environmentIntimate knowledge of the regulatory requirements set out in EU GMP Annex 1: Manufacture of Sterile Medicinal products.Ability to add value, reduce costs and make business improvementsExperience of operating and influencing at a strategic levelKnowledge and technical understanding of sterile manufacturing processes.What you will get in returnWe offer employees not only a competitive salary but also an excellent suite of benefits including:30 days holiday and your birthday off!Company contributory pension packageLife insuranceUpperton Rewards discount platform through reward gatewayPrivate Medical Insurance through VitalityInternal and external training courses and professional development supportFree onsite car parkingEV scheme with Octopus energyWe know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fund raising events.TPBN1_UKTJ