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 Responsibilities CMC & Development Lead and support CMC development activities for biologic drug substances and drug products Act as a CMC subject-matter expert for one or more clinical or commercial biologics Contribute to control strategy development (CQAs, CPPs, specifications) Support process characterization, comparability, and change control Oversee analytical method development, qualification, and validation for biologics Review and interpret stability, release, and characterization data Regulatory & Documentation Author, review, and maintain CMC sections of regulatory dossiers: IMPD (EU) CTA IND / BLA (supporting US submissions) MAA lifecycle variations Prepare responses to Health Authority questions (EMA, PEI, FDA) Ensure compliance with ICH guidelines (Q5A–Q6B, Q8–Q12) and EU GMP expectations Support regulatory strategy discussions related to biologics development Manufacturing & External Partners Act as technical CMC lead for CDMOs (drug substance and/or drug product) Support tech transfer, scale-up, and manufacturing readiness Review batch records, deviation reports, and change proposals Participate in manufacturing campaigns and troubleshooting activities Cross-Functional Collaboration Work closely with: Process Development Analytical Development Quality Assurance Regulatory Affairs Clinical & Project Management Represent CMC in project team meetings and governance forums Required Qualifications & Experience Education PhD or MSc in Biotechnology, Biochemistry, Pharmaceutical Sciences, or related field Experience 5–8+ years experience in CMC development for biologics Strong experience with: Monoclonal antibodies, recombinant proteins, or similar biologics EU regulatory submissions (IMPD / MAA) Analytical and/or formulation development for biologics Experience working with external manufacturing partners (CDMOs) Familiarity with German/EU regulatory landscape (EMA, PEI preferred) Technical Skills Deep understanding of: Biologics manufacturing processes Stability and comparability studies Analytical characterization of biologics Solid knowledge of EU GMP and ICH guidelines Ability to critically assess CMC data and risk Soft Skills & Competencies Strong scientific writing skills (English required; German a plus but not mandatory) Comfortable working in small to mid-sized biotech environments Proactive, detail-oriented, and able to manage multiple CMC activities in parallel Confident 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 14 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 6 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 6 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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Senior Data Scientist
vor 12 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
Vor 6 Tagen
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 1 Woche
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...
