Senior CMC Scientist
Vor 5 Tagen
We are seeking a Senior CMC Scientist (Biologics) to support late-stage development and lifecycle management of biologic drug products (e.g. monoclonal antibodies, recombinant proteins, or advanced biologics). This role will play a key part in CMC strategy, regulatory submissions, and technical oversight for EU and global programs.Berlin-based biotech companies typically value hands-on expertise combined with regulatory awareness, and this role reflects that balance.Key ResponsibilitiesCMC & DevelopmentLead and support CMC development activities for biologic drug substances and drug productsAct as a CMC subject-matter expert for one or more clinical or commercial biologicsContribute to control strategy development (CQAs, CPPs, specifications)Support process characterization, comparability, and change controlOversee analytical method development, qualification, and validation for biologicsReview and interpret stability, release, and characterization dataRegulatory & DocumentationAuthor, review, and maintain CMC sections of regulatory dossiers:IMPD (EU)CTAIND / BLA (supporting US submissions)MAA lifecycle variationsPrepare responses to Health Authority questions (EMA, PEI, FDA)Ensure compliance with ICH guidelines (Q5A–Q6B, Q8–Q12) and EU GMP expectationsSupport regulatory strategy discussions related to biologics developmentManufacturing & External PartnersAct as technical CMC lead for CDMOs (drug substance and/or drug product)Support tech transfer, scale-up, and manufacturing readinessReview batch records, deviation reports, and change proposalsParticipate in manufacturing campaigns and troubleshooting activitiesCross-Functional CollaborationWork closely with:Process DevelopmentAnalytical DevelopmentQuality AssuranceRegulatory AffairsClinical & Project ManagementRepresent CMC in project team meetings and governance forumsRequired Qualifications & ExperienceEducationPhD or MSc in Biotechnology, Biochemistry, Pharmaceutical Sciences, or related fieldExperience5–8+ years experience in CMC development for biologicsStrong experience with:Monoclonal antibodies, recombinant proteins, or similar biologicsEU regulatory submissions (IMPD / MAA)Analytical and/or formulation development for biologicsExperience working with external manufacturing partners (CDMOs)Familiarity with German/EU regulatory landscape (EMA, PEI preferred)Technical SkillsDeep understanding of:Biologics manufacturing processesStability and comparability studiesAnalytical characterization of biologicsSolid knowledge of EU GMP and ICH guidelinesAbility to critically assess CMC data and riskSoft Skills & CompetenciesStrong scientific writing skills (English required; German a plus but not mandatory)Comfortable working in small to mid-sized biotech environmentsProactive, detail-oriented, and able to manage multiple CMC activities in parallelConfident communicator with internal teams and external partners
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Senior CMC Scientist
Vor 5 Tagen
Berlin, Deutschland Barrington James VollzeitWe are seeking a Senior CMC Scientist (Biologics) to support late-stage development and lifecycle management of biologic drug products (e.g. monoclonal antibodies, recombinant proteins, or advanced biologics). This role will play a key part in CMC strategy, regulatory submissions, and technical oversight for EU and global programs. Berlin-based biotech...
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Senior CMC Scientist
Vor 6 Tagen
Berlin, Berlin, Deutschland Barrington James VollzeitWe are seeking a Senior CMC Scientist (Biologics) to support late-stage development and lifecycle management of biologic drug products (e.g. monoclonal antibodies, recombinant proteins, or advanced biologics). This role will play a key part in CMC strategy, regulatory submissions, and technical oversight for EU and global programs.Berlin-based biotech...
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Regulatory Affairs Senior Scientist
Vor 5 Tagen
Berlin, Deutschland Barrington James VollzeitWe are seeking a Senior CMC Scientist (Biologics) to support late-stage development and lifecycle management of biologic drug products (e.g. monoclonal antibodies, recombinant proteins, or advanced biologics). This role will play a key part in CMC strategy, regulatory submissions, and technical oversight for EU and global programs. Berlin-based biotech...
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Senior Data Scientist
vor 9 Stunden
Berlin, Deutschland Orbis Internal Positions Vollzeit**Location: Berlin, Germany**: **Salary: Competitive Salary**: **Permanent**: **Senior Data Scientist - Heidelberg or Berlin - Competitive Salary + Further training opportunities, individual working hours, pension schemes and team activities** This leading German Data-Driven software company are currently seeking a Senior Data Scientist to join their IT...
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(Senior) Data Scientist
Vor 5 Tagen
Berlin, Deutschland Experis GmbH Vollzeit(Senior) Data Scientist (gn) **Sie suchen einen neuen Job?**: Im Rahmen einer Festanstellung sucht Experis Sie als **(Senior) Data Scientist(gn)** für unseren Kunden in der IT am Standort Berlin. Finden Sie mit **Experis **den richtigen **Job**! Nutzen Sie unsere Erfahrung und Beratung für Ihre bestmögliche Entwicklung. Als IT Spezialist bringen wir Sie...
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(Senior) Data Scientist
Vor 5 Tagen
Berlin, Deutschland Experis Vollzeit**Sie suchen einen neuen Job?**: Im Rahmen einer Festanstellung sucht Experis Sie als **(Senior) Data Scientist(gn)** für unseren Kunden in der IT am Standort Berlin. Finden Sie mit **Experis **den richtigen **Job**! Nutzen Sie unsere Erfahrung und Beratung für Ihre bestmögliche Entwicklung. Als IT Spezialist bringen wir Sie mit namhaften Unternehmen...
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vor 7 Stunden
Berlin, Deutschland New Yorker Vollzeit**SENIOR DATA SCIENTIST**: **THIS IS US **:"Dress for the moment." is more than just a slogan for us. NEW YORKER makes fashion for real moments. We are looking for employees with passion, the courage to innovate, and a love of creativity, who drive us forward with their personality and enthusiasm and constantly inspire us anew. Uncomplicated, inspiring and...
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Senior Data Scientist
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Berlin, Deutschland SumUp VollzeitThe mission of the risk modelling team is: We develop, serve, maintain and improve ML Models for Fraud and Financial Crime Detection, Prediction and Prevention in SumUp As part of our data science community the **Senior Data Scientist** will develop, deploy and maintain risk models in the realm of pre transactions, securing our login and onboarding process...
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Senior Applied Scientist
Vor 7 Tagen
Berlin, Deutschland Amazon.com VollzeitAt Audible, we believe stories have the power to transform lives. It’s why we work with some of the world’s leading creators to produce and share audio storytelling with our millions of global listeners. We are dreamers and inventors who come from a wide range of backgrounds and experiences to empower and inspire each other. Imagine your future with...
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Senior Data Scientist, Security
vor 2 Wochen
Berlin, Deutschland Amazon Development Center DEU VollzeitBS degree and 6 years of relevant experience or MS degree and 4 years of experience - Industry experience using database languages, such as SQL, and common data science software development and statistical analysis tools (e.g., Python, R, Scikit-learn) - Demonstrated technical leadership in data science and/or machine learning (e.g., tech lead, data science...
