Drug Substance Scientist / Manager (CMC – API)

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

Professional Experience

Skills & Competencies

Additional Information

Company Culture

At Eurofins PSS, our company culture is deeply rooted in our four core values : Teamwork, Integrity, Superlative Customer Satisfaction, and Productivity. We believe in fostering a collaborative environment where every team member is encouraged to contribute their unique expertise and ideas. Our commitment to integrity drives us to uphold the highest ethical standards in all our endeavors. We strive for superlative customer satisfaction by understanding and exceeding our clients' expectations. Embracing productivity, we continuously seek innovative ways to streamline processes and deliver exceptional results. Together, these values form the foundation of a supportive and empowering workplace, enabling us to achieve excellence in everything we do.

Opportunities for Growth

As part of our commitment to employee development, we offer abundant growth opportunities at Eurofins PSS. You'll have access to learning and development programs, coaching & mentorship, and the chance to take on challenging projects, empowering you to achieve your professional aspirations.

Equal Opportunity Employer Statement

At Eurofins PSS, we are dedicated to being an equal opportunity employer, embracing diversity, and cultivating an inclusive workplace where every individual's unique background and perspective are valued, respected, and celebrated.

Please note that as per Eurofins policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that Eurofins will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.