CMC Specialist

CMC Specialist

TFS HealthScience

Remote, Denmark

Key Responsibilities

• Provide CMC expertise in small molecule and ADC-related projects, focusing on drug substance synthesis and drug product manufacturing.
• Collaborate with internal teams and external Contract (Development) Manufacturing Organizations (C(D)MOs) to ensure alignment with project goals and regulatory standards.
• Support process development, scale-up, and technology transfer activities.
• Ensure compliance with cGMP and contribute to quality risk assessments and documentation.
• Translate project objectives into actionable CMC deliverables and drive them to completion within timelines.
• Act as a subject matter expert, advising on strategy, process improvements, and regulatory readiness.

Qualifications

• MSc or BSc in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.
• Minimum of 5 years’ experience in CMC within the pharmaceutical industry, with a focus on small molecule drug substance and drug product activities.
• Hands-on experience with manufacturing, synthesis, and ideally ADC (Antibody-Drug Conjugate) processes.
• Proven experience working with C(D)MOs and external manufacturing partners.
• Solid knowledge of cGMP and regulatory expectations.
• Strong analytical, planning, and execution skills with the ability to work independently.
• Excellent communication skills in English; other Nordic languages are an advantage.