Senior CMC Scientist

Vor 6 Tagen

Berlin, Berlin, Deutschland Barrington James Vollzeit

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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