CMC Senior ManagerLed by a highly respected entrepreneurial leadership team, blessed with a proven track record in building successful young start-ups, our client is a young, exciting, rapid growing clinical stage biopharmaceutical business poised to deliver an important break though in a debilitating condition characterised by chronic unmet need.This role offers an extraordinary opportunity for a high performer with a depth of expertise in the development of products with particular expertise in drug substance as well as analytical method development. This role is home based.Job SpecThis role will support the development of our client's novel, proprietary drug-device combination products, with responsibilities for leading projects from technical feasibility evaluation, drug development and technical support, through commercial registration. The preferred candidate will have experience of pharmaceutical development, with particular expertise in analytical method development and interpretation of results. Experience in bringing drug product from phase 3 to commercialisation.Key Duties and Responsibilities:Technical lead for the development and manufacture of drug substance in accordance with the relevant guidance & regulations and in alignment with company goals and clinical development plan.Oversee the development, validation and technical transfer of drug substance (DS) and drug product (DP) analytical methods and completion of all testing.Perform data analysis, trending and monitoring of all development data using statistical methods as appropriate and providing technical interpretationActively keep abreast of all changes and proposed changes in the pharmacopeia (e.g. USP, EP) and other regulatory guidance (FDA, EMA, ICH etc.) which might impact analytical testing activities. This includes starting materials, API, excipients, drug products and drug-device combination products.Contribute to the development of DS & DP specifications with supporting justifications, in line with the phases of development through to registration.Management and oversight of all DS and DP stability testing in line with ICH guidance, including definition of the strategy, test plan and data analysis & trending.Authoring and review of CMC sections of regulatory submission documentation for FDA, EMA and other regions as required from clinical phases through to marketing authorisation.Management of CMOs, test labs, scientific advisors, regulatory advisors as needed to achieve CMC goals.Liaise with other Technical Development functions including Drug Product, Device Development & Engineering to provide technical support as required in the overall development of proprietary drug-device combination products.Person SpecYou will have a passion to make a difference to patients lives working in an innovation led fast paced clinical staged business.Minimum of Master's Degree in Chemistry, Pharmaceutical Sciences, or equivalentMinimum 8 years' experience in technical development of drug substance and/or drug product in pharmaceutical and/or biotech company.Experience in development of products for pulmonary delivery beneficial.Expertise in analytical chemistry supporting all phases of drug development programs (methods development, validation and specification setting).Expert in quality impact assessments and conducting troubleshooting. Proven ability to conduct quality incident investigations (OOS, OOT, Deviations and Investigations).Experience in pharmaceutical development from early to late stage inclusive of GMP/clinical supply manufacture.Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory.Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines.Experience interacting with third party service providers required.Self-motivated with the ability to work in a fast-paced environment.Acute attention to detail supported by the ability to see the big picture.Strong organizational, planning, problem-solving, analytical and decision-making skills.An entrepreneurial, business-oriented mindset with a focus on our core values of collaboration, people and the pursuit of excellence, while prioritising the outcomes for the patient in every decision and action.Resilient, energetic, and enthusiasticCv to