Drug Substance Scientist Manager (CMC – API)
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Job Location:
St. Gallen - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking an experienced Drug Substance Scientist / Manager (CMC API) to support our client in the development scaleup and GMP manufacturing of a new smallmolecule drug substance in close collaboration with external CDMOs. This is a purely industryfocused role applied processoriented 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 drugsubstance 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 GMPcompliant 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 processdevelopment 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
- 58 years of industry experience in smallmolecule API development process chemistry MSAT or API manufacturing.
- Handson 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 Q8Q11 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.
- Detailoriented 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. Youll 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 individuals 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
