CMC- Senior product developer

vor 2 Wochen

Munich, Deutschland S3 Science Recruitment Vollzeit

CMC ConsultantLooking for consultants ranging from a minimum if 5 years to 15+ years experience in CMC.The CMC Consultant acts as a subject matter expert across drug substance and drug product development, covering a broad range of modalities (small molecules, oligonucleotides, biologics) and dosage forms (oral, sterile, nanoparticle formulations). This role supports projects from pre-clinical development through to commercial approval, ensuring CMC strategy, documentation and execution align with global regulatory expectations.Tasks & ResponsibilitiesProvide expert guidance on quality and CMC regulatory aspects of drug development, collaborating closely with cross-functional stakeholders.Ensure CMC work-packages and documentation are phase-appropriate, regulatory compliant and supportive of global submissions.Prepare CMC sections of IND/IMPD and BLA/NDA/MAA submissions.Perform CMC gap analyses, identify critical development risks, and define mitigation strategies.Support due diligence assessments as required.Prepare briefing packages for regulatory agency interactions (e.g., Scientific Advice, EoP2) and participate in agency meetings alongside project teams.Lead operational and strategic interactions with CDMOs.Coordinate regulatory filing activities with internal and external contributors.Maintain up-to-date understanding of evolving regulatory guidance and expectations.RequirementsPh.D. or Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or related field.Minimum 5 years in CMC development and/or CMC Regulatory Affairs.Hands-on experience with global regulatory filings (IND/IMPD, BLA/NDA/MAA).Strong communication, stakeholder management and negotiation skills in English.(Additional language skills are a plus.)Familiarity with CMC expectations across pre-clinical to late-stage or commercial development.Team-oriented with strong interpersonal skills.Proficient in MS Office.Willingness to travel occasionally for client, partner, or agency meetings.What’s OfferedCollaborative and professional working environment alongside experienced industry experts.Competitive salary package with performance-based bonus structure.Opportunities to work across diverse therapeutic areas and modalities, developing strategic and scientific depth.

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