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