Senior Director CMC
hace 2 días
Get AI-powered advice on this job and more exclusive features.Envíe su CV y cualquier información adicional requerida después de haber leído esta descripción, haciendo clic en el botón de solicitud.Direct message the job poster from Discover InternationalSenior Consultant | Tech Ops | Pharma & BiotechDirector / Senior Director, CMC (Chemistry, Manufacturing & Controls)Confidential | Next-Generation Bioconjugate Therapeutics | Flexible LocationA fast-growing, well-funded biotechnology company developingnext‑generation hybrid biologic/nucleic acid therapeuticsis seeking an experiencedDirector / Senior Director, CMCto lead all CMC strategy, development, and execution from early R&D through clinical supply.This is a rare opportunity to shape the CMC function for an emerging platform and play a pivotal role in advancing transformational therapies. The team welcomes applicants across Europe and beyond, withflexible hybrid/remote optionsfor exceptional candidates.The RoleDefine and deliver an integrated CMC strategy supporting early development to first‑in‑human studiesLead cross‑functional planning, risk assessments, and decision‑making at the interface of R&D, Quality, Regulatory, and external partnersOversee process development for both biologic and nucleotide‑based components, including conjugation and purificationGuide tech transfers and manufacturing with global CDMOs (DS & DP)Direct analytical method development and characterization for complex bioconjugatesLead CMC authoring for regulatory submissions (pre‑IND, IND/IMPD)Partner with Quality to implement phase‑appropriate systems supporting cGMP operationsManage vendor selection, contracting, and performance oversightRepresent CMC in leadership updates, program reviews, and regulatory discussionsWhat We’re Looking ForPh.D. or M.S. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field10+ years of CMC experience in biologics, bioconjugates, ADCs, or synthesis of nucleic acid polymersStrong expertise in process development, analytical development, and cGMP manufacturingSolid understanding of bioconjugation chemistry and/or nucleic acid synthesisExperience leading CMC content for regulatory filings and engaging with authoritiesDemonstrated success managing CDMOs across early‑stage developmentComfortable working in a fast‑paced, entrepreneurial biotech environmentPreferred:experience with complex conjugate modalities, early‑stage biotech, or AI‑assisted CMC analytics. xsgfvud Why This Role?Influence CMC strategy and infrastructure from the ground upWork on a technically exciting and emerging therapeutic classCollaborate with a world‑class scientific team and top‑tier external partnersCompetitive compensation, equity, and flexible working optionsSeniority LevelDirectorEmployment TypeFull‑timeJob FunctionManufacturing, Research, and Project ManagementIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing#J-18808-Ljbffr
-
Senior Director CMC
hace 2 semanas
Madrid, España Discover International A tiempo completoGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Discover InternationalSenior Consultant | Tech Ops | Pharma & Biotech Director / Senior Director, CMC (Chemistry, Manufacturing & Controls)Confidential | Next-Generation Bioconjugate Therapeutics | Flexible LocationA fast-growing, well-funded biotechnology...
-
Senior Director CMC
hace 2 semanas
Madrid, España Discover International A tiempo completoGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Discover InternationalSenior Consultant | Tech Ops | Pharma & Biotech Director / Senior Director, CMC (Chemistry, Manufacturing & Controls)Confidential | Next-Generation Bioconjugate Therapeutics | Flexible LocationA fast-growing, well-funded biotechnology...
-
Senior Director CMC
hace 2 semanas
Madrid, España Discover International A tiempo completoGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Discover InternationalSenior Consultant | Tech Ops | Pharma & BiotechDirector / Senior Director, CMC (Chemistry, Manufacturing & Controls)Confidential | Next-Generation Bioconjugate Therapeutics | Flexible LocationA fast-growing, well-funded biotechnology company...
-
Senior Director, CMC — Biotech Bioconjugates
hace 2 semanas
Madrid, España Discover International A tiempo completoA leading biotechnology company is seeking an experienced Director/Senior Director, CMC to oversee the CMC strategy and its execution. Applicants with a Ph.D. or M.S. in Chemistry and over 10 years of CMC experience in biologics are encouraged to apply. The role offers competitive compensation, equity, and flexibility, making it a unique opportunity to play...
-
Senior Director, CMC — Biotech Bioconjugates
hace 2 días
Madrid, España Discover International A tiempo completoA leading biotechnology company is seeking an experienced Director/Senior Director, CMC to oversee the CMC strategy and its execution.Si desea conocer los requisitos para este puesto, siga leyendo para obtener toda la información relevante.Applicants with a Ph.D.or M.S.in Chemistry and over 10 years of CMC experience in biologics are encouraged to apply.The...
-
Senior Director Global CMC Strategy
hace 2 semanas
Madrid, España Viatris A tiempo completoGenerics (U.K.) Ltd.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access – Providing high quality trusted medicines regardless of...
-
Cmc strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge's Client is looking for an individual to help with their CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation@Spain (100 % Remote Working) Key area:Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely data...
-
CMC Strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with their CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working) Key Area Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely...
-
CMC Strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with theirCMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working)Key AreaProvide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation.Coordinate with manufacturing and quality teams to ensure accurate and timely data...
-
CMC Strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with theirCMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working) Key area:Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely...
