Drug Substance Scientist/Manager (CMC - API)

Drug Substance Scientist/Manager (CMC - API)

Eurofins

St Gallen, Switzerland

Job Description

We are seeking an experienced Drug Substance Scientist / Manager (CMC – API) to support our client in the development, scale‑up, and GMP manufacturing of a new small‑molecule drug substance in close collaboration with external CDMOs. This is a purely industry‑focused role — applied, process‑oriented, and directly linked to manufacturing readiness. It is not a basic research or academic laboratory position.

You will work at the interface of development, manufacturing, and quality to ensure robust API processes and a compliant drug‑substance supply for preclinical and clinical stages.

Key Responsibilities

• Contribute to Quality by Design (QbD) activities including CQA assessments, process FMEA, parameter criticality, and comparability assessments;
• Evaluate CDMO development proposals, manufacturing data, deviations, and campaign performance;
• Support GMP‑compliant API production, including review of batch records, investigations, and change controls;
• Coordinate CDMO interactions and contribute to defining and tracking technical and operational KPIs;
• Prepare clear reports and presentations; communicate results effectively to internal project teams;
• Support setting of API specifications and contribute to SOP updates related to QbD and process development;
• Identify digitalization needs and support implementation efforts within the CMC team;
• Develop internal training materials related to QbD concepts and process‑development tools.

Qualifications

Education

• MSc or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field;
• Bachelor/Fachhochschule (FH) degree in Chemistry, Chemical Engineering, Life Sciences, or related applied sciences;
• Laborant/in EFZ Chemie (Swiss chemical laboratory technician) with strong industry experience in API process development, MSAT, or GMP manufacturing;
• Important: Candidates with primarily academic/basic science backgrounds and no industrial exposure will not be considered.

Professional Experience

• 5–8+ years of industry experience in small‑molecule API development, process chemistry, MSAT, or API manufacturing;
• Hands‑on experience working with CDMOs in development or GMP settings;
• Familiarity with GMP, including batch documentation, deviations, and change control;
• Practical knowledge of QbD, process risk assessments, and ICH Q8–Q11 guidelines.

Skills & Competencies

• Ability to interpret process and analytical data and derive meaningful conclusions;
• Excellent technical writing skills (reports, presentations, SOPs);
• Clear and structured communication across internal and external stakeholders;
• Detail‑oriented, compliant, and aligned with industry documentation standards;
• Proficiency in English (written and spoken) required; German is beneficial.