Senior CMC Scientist

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