Job Description
CMC Manager Our 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 CMC Manager will lead projects from the technical feasibility evaluation through commercial registration of the company drug product portfolio. The preferred candidate will have experience of drug development, including drug substance development and the accompanying analysis as well as strong vendor management. This role can be hybrid or remote within in Ireland, Europe or the UK. Job Spec Contribute to the strategy for development and clinicalstudyproductionofcompanydrugproductsand drug substancein alignment with company goals and clinical plans. OverseeCMCrelated activities with vendors and internally: build out and implement a control strategy build; PPQ. Ensure all DS and DP-related processes are in line with health, safety,environmentalandqualityrequirementsincluding regulations, policies, applicable guidelines and procedures. Reviewlanalytical data, development reports and protocols, work orders and quotes related to CMC. Summarize and present CMC, development plans, activities and outputs to management or other departments. Contribute and review CMC related regulatory documents such as product development reports for regulatoryfilings. ManagementofCMOs,scientificadvisors,regulatory advisors as needed to achieve CMC goals. Assistingindefiningsupply strategies for DS and DP required for clinical trials and product launch. Manage drug substance and clinical supply including raising shipments and updating inventory, experience with controlled drug would be desirable. Liaise with other CMC functions including Drug Product, Analytical and Engineering/Device to provide technical support in establishment of specifications and analytical methodology. Provide data interpretation and perform data trending andmonitoringusingstatisticalmethodsasappropriate. Supporttheidentificationandselectionofsuitabledevelopment and commercial manufacturing vendors (CMOs). Assistingincoordinatingtheassemblyofregulatory packages, both towards FDA and EMA. Person Spec Minimum8yearsexperiencein drug substance, drug product, or project management in a CMC function in a pharmaceutical and/or biotech company or CRO. Experienceonauthoring and reviewingCMCdocumentation. Experience in Drug product development from early to latestageinclusiveofGMP/clinicalsupplymanufacture. Experience with regulatory documentation for CMC activitiesondrugsubstance,drugproductbothtowards FDA and EMA is mandatory. Solidexperiencewithworkinginaregulatedenvironment underGxPandwithadherencetoCompanySOPs,policies and guidelines. UpdatedknowledgeofICHGMPisrequired. 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. CVs to Laurentina Kennedy at The RFT Group at . Skills: CMC Drug Substance Drug Product