AD Formulation and Process Developement

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The Company A biopharmaceutical 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, primary care and rheumatology business units. The role is in the company's Global headquarters are in Dublin, Ireland. They also have offices in the US and Europe.They are currently looking to recruit an Associate Director Formulation and Process development.The Position Reporting to the Executive Director, Technical Operations - Biologics, you will bring scientific and technical knowledge to the organization related to the development of formulations and processes for sterile dosage forms, especially for biologics.The position will encompass all technical operations activities for example, establishment and implementation of new formulations, site transfer activities, upscale, validation for existing and new products to be in-licensed into the product portfolio.This is a virtual role where interaction with CMOs and CROs is a critical aspect of the job function as well as the internal cross-functional cooperation with R&D and other TechOps functions such as Quality, Manufacturing, and Supply Chain Management. Additional responsibilities include authoring and reviewing development plans, technical protocols and reports and authoring of specific sections of the CMC portion of regulatory dossiers.Qualifications and Skills Required: Extensive experience in formulation and process development of sterile dosage forms (for example, liquids and freeze-dried products, prefilled syringes, auto injectors).Demonstrated expertise in excipient screening using DoE approaches.You will ideally have an analytical background with method development expertise, thus understanding the structural and functional attributes of proteins in order to assess the stability of the developed formulations, for example HPLC-SEC, RP-HPLC, MFI, CIEX, CIEF.Demonstrated experience in developing freeze-drying cycles for therapeutic proteins.Bachelor's degree in engineering or an applied science is required. An advanced degree is advantageous.Over five to 10 years of relevant pharmaceutical development and manufacturing experience in Biologics.Nor sure yet? No CV ready? Give me a call for more information. 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