Manager/ Senior Manager Drug Product Manager
2 months ago
Manager/ Senior Manager Drug Product ManagernOur client, a rapidly growing publicly listed clinical stage biopharmaceutical company, are currently recruiting for a Manager/ Senior Manager Drug Product Manager to join their team on a permanent basis.nAs Manager/Senior Manager Drug Product, you will lead projects from the technical feasibility evaluation through to commercial registration of the company drug product portfolio.
Drug product formulation for inhaled products in combination with drug product development as well as strong vendor management are essential skills for this role.
This role can be based remotely in Ireland, or the UK.
ResponsibilitiesnDevelop and execute the strategy for development and clinical study production of company drug products in alignment with company goals and clinical plansnOversee all CMC-DP for inhalation combination drug product related activities with vendors: formulation and process development for use with device, technical transfer; scale-up; control strategy build and implementation; PPQnEnsure all DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and proceduresnDevelop and control appropriate budgets and timelines for the delivery of CMC-DP in line with company goalsnReview and technical approval of all analytical data, development reports and protocols, work orders and quotes related to CMC- DPnSummarize and present CMC-DP, development plans, activities and outputs to management or other departments in support of product developmentnProvide CMC-DP and Combination product-related regulatory documents such as product development reports for regulatory filings, inclusive of management, reviewing, updating and authoringnManage CMOs, scientific advisors, regulatory advisors as needed to achieve CMC-DP goalsnAssist in defining regulatory strategies both towards FDA, EMA and required marketsnProvide Leadership and Expertise in Inhalation Drug product development and analysis/testing as an SME in the fieldnLiaise with other CMC functions including Drug Substance, Analytical and Engineering/Device to provide technical support in establishment of specifications and analytical methodology.
RequirementsnMinimum 8 to 10 years' experience as a drug project manager in a pharmaceutical and/or biotech company or CROnExperience on CMC documentation for respiratory devices is importantnExperience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacturenExperience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatorynSolid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelinesnUpdated knowledge of ICH GMP is requirednExcellent communication, presentation, and interpersonal skills.
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