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