CMC- Senior product developer

S3 Science Recruitment; München; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A specialized recruitment agency is seeking a CMC Consultant to provide expert guidance on regulatory aspects of drug development. The role requires a minimum of 5 years of CMC development experience and involves preparing submissions for regulatory agencies. Candidates should have strong communication and negotiation skills, a relevant advanced degree, and proficiency in MS Office. This position offers a competitive salary and opportunities to work with industry experts across various therapeutic areas.

Leistungen

Competitive salary package

Performance-based bonus structure

Collaborative working environment

Qualifikationen

• Minimum 5 years in CMC development and/or CMC Regulatory Affairs.
• Hands-on experience with global regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Familiarity with CMC expectations across development stages.

Aufgaben

• Provide expert guidance on quality and CMC regulatory aspects of drug development.
• Prepare CMC sections for various submissions (IND/IMPD, BLA/NDA/MAA).
• Perform CMC gap analyses and define mitigation strategies.

Kenntnisse

Quality CMC regulatory guidance

Stakeholder management

Negotiation skills

MS Office proficiency

Ausbildung

Ph.D. or Master’s degree in relevant field

Jobbeschreibung

CMC Consultant

Looking 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 & Responsibilities

• Provide 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.

Requirements

• Ph.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 Offered

• Collaborative 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.