Job Description
Product Development Manager - Pharmaceutical (solid oral dose)\n\nCambridge\n\nPermanent\n\n£ competitive, depending on skills, background and experience\n\nScope of the role:\n\nThis is an exciting new role which will see you taking responsibility for technical and analytical knowledge of the business product portfolio as well as guiding projects through the commercial phase.\n\nYou will work on projects within a range of therapeutic areas including: metabolic, immunology and neurology, exploring a variety of technologies and dosage forms. Building both an internal and external network, your strong commercial acumen and client-facing skills will be invaluable to supporting the business growth plans and patient network.\n\nResponsibilities:\n\nTechnical expert: providing formulation and analytical expertise to support commercial products, in collaboration with product management, and Quality and Regulatory affairs teams.\nBuild and maintain strong working relationships with new and existing third party vendors.\nSupport commercial manufacture of products through conducting gap analysis, review stability data and help to optimise manufacture process efficiency.\nInvestigate issues and risks for commercial projects; design suitable scope of works and manage project execution with CMO's.\nKeep abreast of regulatory updates, particularly US/FDA.\nPrepare and review technical documentation, work to SOPs and internal protocols.\nRepresent the team in budget discussions, identify spend and savings opportunities and contribute to the operational planning around timelines and milestones.\nTrain and develop internal stakeholders to ensure they are enabled to progress and develop.\nSuggest methods for improvement of procedures, identify cost and time saving measures and help implement solutions which address efficiency and consistency. \n\nYour background:\n\nDegree or equivalent in a Life Science discipline.\nDrug product formulation experience which must be from Phase 2 or beyond in either of the following: oral solid dose form or solutions and suspensions.\nExperience with analytical method development and validation would be very beneficial.\nYou will have worked with tech transfer processes of product manufacturing to commercial scale.\nExcellent commercial acumen and proven success in client-facing roles.\nGood awareness of ICH guidelines.\nStrong negotiation and influencing skills, particularly in relation to vendor management of third party CMO/CRO's\nAbility to work independently, with minimal supervision in a dynamic environment with regularly changing demands.\nResults and solutions-oriented, highly organised and collaborative.
\n\nIf this sounds like it could be your next role, please apply here or contact for more information.\n\nCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy