Sr. Analytical Scientist

Job Description

The Senior Analytical Scientist plays a key role in the development, optimization, and implementation of analytical methods to support pharmaceutical drug product development within the Oculis laboratory. This role has a strong focus on HPLC/UPLC method development and analytical characterization to enable the progression of drug candidates from early development through later development stages.

Position Summary

The position involves hands-on experimental work, scientific data interpretation, and analytical strategy development. The Senior Scientist will lead and execute method development for assay, impurity profiling, and stability-indicating methods, ensuring robust analytical support for formulation, process development, and stability studies.

The role requires close collaboration with cross-functional teams, including technical development, formulation scientists, quality assurance, and early development teams, ensuring analytical activities are conducted in accordance with internal quality standards and regulatory expectations.

Key Responsibilities:

Analytical Method Development (Primary Focus) 

• Design, develop, and optimize HPLC/UPLC analytical methods for drug substance and drug product analysis. 
• Develop stability-indicating methods for assay, degradation products, and impurity profiling.
• Perform method optimization, including selection of columns, mobile phases, gradients, detection wavelengths, and sample preparation procedures.
• Conduct method qualification and support method validation activities according to internal and regulatory guidelines.
• Troubleshoot analytical challenges and continuously improve analytical methodologies to enhance robustness, sensitivity, and reproducibility.

Analytical Characterization 

• Perform physicochemical characterization of drug substances and drug products to support development programs. 
• Conduct analytical testing for assay, impurities, degradation products, and stability studies.
• Utilize analytical techniques such as HPLC/UPLC, UV-Vis spectroscopy, dissolution testing, pH measurement, osmolality, and particle size analysis.
• Interpret analytical data to support formulation development, process optimization, and product stability assessment.
• Contribute to the identification of critical quality attributes (CQAs) and support development strategies. 

Documentation & Compliance 

• Maintain accurate and detailed analytical documentation, laboratory notebooks, and data records in accordance with internal quality systems.
• Author and review analytical protocols, standard operating procedures (SOPs), and technical reports. 
• Contribute to development reports, regulatory documentation, and CMC sections when required.
• Ensure analytical activities comply with applicable regulatory expectations, quality standards, and laboratory safety guidelines.

Collaboration & Scientific Leadership

• Work closely with cross-functional project teams to provide analytical expertise throughout product development. 
• Present analytical results, scientific insights, and development recommendations during internal project meetings. 
• Mentor junior scientists or laboratory staff where applicable. 
• Identify opportunities to improve analytical workflows, laboratory efficiency, and analytical strategies. 

Necessary Skill Set:

Experience

• Minimum 5-8 years of relevant experience in analytical development within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in HPLC/UPLC method development for pharmaceutical products. 
• Experience developing stability-indicating analytical methods for drug substances and drug products.

Skills 

• Strong expertise in chromatographic method development (HPLC/UPLC), including column selection, gradient optimization, and method troubleshooting.
• Experience with impurity profiling, degradation studies, and stability testing. 
• Familiarity with analytical techniques such as UV-Vis spectroscopy, dissolution testing, pH measurement, osmolality, and particle size analysis.
• Experience with analytical method qualification, validation, and method transfer.
• Knowledge of pharmaceutical development principles and regulatory expectations (e.g., ICH guidelines). 
• Strong scientific data interpretation and problem-solving abilities. 
• Excellent technical writing and documentation skills. 
• Strong communication skills and ability to present analytical data clearly.
• High level of attention to detail and data integrity awareness. 
• Strong organizational and time-management skills. 
• Fluent in English (written and spoken) 

Education 

• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline

Oculis Sàrl is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.