Senior Director CMC
hace 4 días
Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Discover International Senior Consultant | Tech Ops | Pharma & Biotech Director / Senior Director, CMC (Chemistry, Manufacturing & Controls) Confidential | Next-Generation Bioconjugate Therapeutics | Flexible Location A fast-growing, well-funded biotechnology company developing next‐generation hybrid biologic/nucleic acid therapeutics is seeking an experienced Director / Senior Director, CMC to 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, with flexible hybrid/remote options for exceptional candidates. The Role Define and deliver an integrated CMC strategy supporting early development to first‐in‐human studies Lead cross‐functional planning, risk assessments, and decision‐making at the interface of R&D, Quality, Regulatory, and external partners Oversee process development for both biologic and nucleotide‐based components, including conjugation and purification Guide tech transfers and manufacturing with global CDMOs (DS & DP) Direct analytical method development and characterization for complex bioconjugates Lead CMC authoring for regulatory submissions (pre‐IND, IND/IMPD) Partner with Quality to implement phase‐appropriate systems supporting cGMP operations Manage vendor selection, contracting, and performance oversight Represent CMC in leadership updates, program reviews, and regulatory discussions What We're Looking For Ph.D. or M.S. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field 10+ years of CMC experience in biologics, bioconjugates, ADCs, or synthesis of nucleic acid polymers Strong expertise in process development, analytical development, and cGMP manufacturing Solid understanding of bioconjugation chemistry and/or nucleic acid synthesis Experience leading CMC content for regulatory filings and engaging with authorities Demonstrated success managing CDMOs across early‐stage development Comfortable working in a fast‐paced, entrepreneurial biotech environment Preferred: experience with complex conjugate modalities, early‐stage biotech, or AI‐assisted CMC analytics. Why This Role? Influence CMC strategy and infrastructure from the ground up Work on a technically exciting and emerging therapeutic class Collaborate with a world‐class scientific team and top‐tier external partners Competitive compensation, equity, and flexible working options Seniority Level Director Employment Type Full‐time Job Function Manufacturing, Research, and Project Management Industries Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing #J-18808-Ljbffr
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Senior Director CMC
hace 1 semana
Madrid, España Discover International A tiempo completoGet 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,...
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Senior Director, CMC — Biotech Bioconjugates
hace 1 semana
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...
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Cmc strategist
hace 3 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...
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CMC Strategist
hace 3 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...
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Operational Innovations Director/Senior Manager
hace 3 semanas
Madrid, España Mantell Associates A tiempo completoMantell Associates are proudly partnered with a leading CDMO in their search for a Director of Operations to join their senior leadership team. Director of Operations - Responsibilities:Los candidatos deben tomarse el tiempo de leer atentamente todos los elementos de este anuncio de empleo. Por favor, envíen su solicitud sin demora.Work alongside the senior...
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Operational Innovations Director/Senior Manager
hace 2 semanas
Madrid, España Mantell Associates A tiempo completoMantell Associates are proudly partnered with a leading CDMO in their search for a Director of Operations to join their senior leadership team. Director of Operations - Responsibilities:Work alongside the senior leadership team to define operational strategy and directionLead the function ensuring that appropriate scientific, regulatory, and quality...
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Operational Innovations Director/Senior Manager
hace 1 semana
Madrid, España Mantell Associates A tiempo completoMantell Associates are proudly partnered with a leading CDMO in their search for a Director of Operations to join their senior leadership team.Director of Operations - Responsibilities: Work alongside the senior leadership team to define operational strategy and direction Lead the function ensuring that appropriate scientific, regulatory, and quality...
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Senior Global CMC Regulatory Affairs Manager
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madrid, España Oxford Global Resources A tiempo completoA leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharma company in Barcelona. This role involves providing regulatory insight, ensuring compliance with global regulations, and collaborating with various teams. Candidates must have a Bachelor's degree in Life Sciences, at least 5 years of experience in...
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Compliance Analyst
hace 2 semanas
Madrid, España CMC Markets A tiempo completoPurpose of the role: The Compliance Analyst will be responsible for delivering regulatory oversight of changes applicable to the Firm with focus on Financial Promotions within the investment services sector; providing support to the review and approval of financial promotions to the Spanish Branch of CMC Markets Germany GmbH. THIS IS A PART TIME ROLE (20...
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Operational Innovations Director/Senior Manager
hace 2 semanas
Madrid, España Mantell Associates A tiempo completoMantell Associates are proudly partnered with a leading CDMO in their search for a Director of Operations to join their senior leadership team.Los candidatos deben tomarse el tiempo de leer atentamente todos los elementos de este anuncio de empleo. Por favor, envíen su solicitud sin demora.Director of Operations - Responsibilities:Work alongside the senior...
