Manufacturing Operations Manager

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The CompanyBiopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.The company has a portfolio of medicines through its orphan and inflammation groups. Horizon's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.The PositionReporting to the Director of Manufacturing Operations, the Manager Manufacturing operations position is responsible for support & oversight of manufacturing operations of companies commercially marketed products.This is a role for a professional who has a solid foundation of experience in a biotechnology manufacturing plant. It is a career development opportunity to gain further experience with a wide range of products and technologies as well as collaborating with a set of functions such as Development and Supply Chain.ResponsibilitiesEnsures large scale commercial batch processing continuously meets Safety, Identity, Strength, Purity and Quality (SISPQ) requirementsWork closely with Contact Manufacturing Organisations (CMO's) to drive improvements in manufacturing processes and operationsDevelop effective collaborative working relationships with counterparts within CMOsAssesses, approves and oversees implementation of process related change controls and Corrective Actions (CAPA's)Provides technical direction to resolve immediate process issuesInterfaces regularly and builds strong working relationships with other departments, such as Process Development, Quality Assurance, Quality Control, Supply Chain and Project ManagementReviews, and/or approves Batch records, Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededHave oversight of CPV programs being developed and review and trend data as requiredParticipates in continuous process monitoring to identify areas of focus for continuous improvement and process robustnessEnsure that the systems internal to the Manufacturing Operations function consistently and meet all cGMP and other regulatory requirementsEnsures investigations and deviations are managed and closed in a timely manner to meet compliance standardsQualifications and Skills Required:Master's degree in Biochemistry, Pharmacy, Engineering or related field3 years' experience within manufacturing or technical operations in the pharmaceutical (biologics industry). This should be in a manufacturing drug substance process roleExperience with leading investigations, using investigational tools and QMS systemsThorough understanding of good manufacturing/laboratory practices (GMP/GLP) and regulatory compliance/documentation requirementsProven track record in identifying opportunity, engaging in cross-functional improvement efforts.Ability to support regulatory submissionsInternational travel of up to about 2 weeks at a time will periodically be required when circumstances allowNot sure yet? No CV ready please get in touch for more details? For immediate consideration please apply with an up to date CV. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales