Drug Product ManagerOur client is an exciting, rapid growing publicly listed clinical stage biopharmaceutical business focussed on establishing best in class teams across all its functions. In 2021, the company successfully completed an IPO on the Nasdaq. To date, the company has raised $300 million +, and is engaged in a major expansion of its team in Ireland. The main task of the Manager, Drug Product, is to lead projects from the technical feasibility evaluation through commercial registration of the company drug product portfolio. This role can be based in or in close proximity to Dublin, or alternately in the Home Counties in England.Job Spec· Develop and execute the strategy for development and clinical study production of company drug products in alignment with company goals and clinical plans.· Oversee all CMC-DP and Combination Product related activities with vendors: formulation and process development, technical transfer; scale-up; control strategy build and implementation; PPQ.· Ensure all DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.· Develop and control appropriate budgets and timelines for the delivery of CMC-DP and company goals.· Review and approval (technical approval) of all analysis data, development reports and protocols, work orders and quotes related to CMC- DP.· Summarize and present CMC-DP and Combination Product plans, activities and outputs to management or other departments in support of product development.· Responsible for providing CMC-DP and Combination product-related regulatory documents to authorities/regulatory filings, inclusive of management, updating and authoring.· Management of CMOs, scientific advisors, regulatory advisors as needed to achieve CMC-DP goals.· Assisting in defining regulatory strategies both towards FDA, EMA and required markets.· Provide Leadership and Expertise in Inhalation Drug product development and analysis/testing as an SME in the field.· Liaise with other CMC functions including DS and Analytical to provide technical support in establishment of specifications and analytical methodology. Support device regulated development and required DP assistance to device and combination product development activities.· Provide data interpretation and perform data trending and monitoring using statistical methods as appropriate.· Support URS and PURs of manufacturing equipment.· Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).· Develop knowledge and create IP opportunities for the portfolio.· Assisting in coordinating the assembly of regulatory packages, both towards FDA and EMA.Person Spec· Minimum 8 to 10 years' experience as a project manager in a pharmaceutical and/or biotech company or CRO.· Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory.· Experience on CMC documentation for respiratory devices is preferred.· Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture.· Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines.· Updated knowledge of ICH GMP is required.· Excellent communication, presentation, and interpersonal skills.· Self-driven and motivated team player.· Familiar with working in a virtual set-up.· Fluent in written and spoken professional English.CV to Gerry Kennedy at / ++353 (0) 1 2302400PAGE1
