Drug Substance Scientist / Manager (CMC – API)

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Eurofins seeks a Drug Substance Scientist/Manager (CMC API) to lead development, scale‑up and GMP manufacturing, collaborating with external CDMOs in St. Gallen, Switzerland. The role bridges development, manufacturing and quality to ensure robust processes and compliant supply for preclinical and clinical stages. Core duties include QbD activities, evaluating CDMO proposals, reviewing batch records and change controls, coordinating CDMO interactions, tracking KPIs, and producing reports. Requirements: 5–8+ years in small‑molecule API development or GMP manufacturing, MSc/PhD or FH degree, CDMO and GMP experience, English; German a plus. Apply with a CV that highlights hands‑on API development, measurable CDMO outcomes, QbD and regulatory know‑how. Onsite in St Gallen.

Company Description

Eurofins Scientific is an international life sciences company that offers customers from various industries a unique range of analytical services to make life and our environment safer, healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on, Eurofins works with the world's largest companies to ensure the products delivered are safe, theirs Ingredients are authentic and labeling is accurate. The company is a leading global provider of analytics for food, environmental, pharmaceutical and cosmetic products as well as contract research (CRO) services.

Eurofins has more than 900 laboratories within its global network, employing over 62’000 staff.

Eurofins Professional Scientific Service® (PSS) is a global insourcing solution for our customers. Together with the customer, we define a project for the required services that our Eurofins employees should provide at the customer's location. During the ongoing project, the responsibility for project management, the previously defined laboratory services and the deployment of our employees in this project lies with Eurofins PSS.

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.

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.