Scientist, Analytical Operations

Key Responsibilities

• Provide technical leadership in the development and optimization of analytical methods for complex or challenging assignments.
• Define analytical strategies, approaches, and techniques that address technical needs and advance project objectives.
• Design, plan, and execute laboratory experiments to resolve complex analytical and development challenges.
• Maintain a strong hands-on laboratory presence and apply scientific judgment to troubleshoot experiments, interpret data, and resolve technical issues.
• Anticipate analytical needs across the drug development process and proactively address evolving project requirements.
• Plan, prioritize, and execute analytical activities for raw materials, intermediates, drug substances, and drug products in alignment with project objectives and development timelines.
• Design and perform physicochemical analyses, including liquid chromatography, gas chromatography, and Karl Fischer analysis.
• Conduct fit-for-purpose development studies, including stress and degradation studies and accelerated stability approaches.
• Develop and apply sensitive analytical methods to assess process-related impurities, mutagenic and potentially mutagenic impurities, and nitrosamines.
• Contribute to scientifically sound impurity control strategies based on analytical findings and development needs.
• Provide analytical expertise to support the development and characterization of formulations, product intermediates, and dosage forms, including solid oral, parenteral, and combination products.
• Apply Quality by Design principles, including Design of Experiments and Method Operable Design Region approaches, consistent with ICH Q14 principles.
• Maintain current knowledge of scientific literature, emerging analytical technologies, and relevant regulatory expectations.
• Lead critical components of cross-functional projects and contribute to departmental initiatives or technology programs.
• Collaborate across functions to solve complex scientific and technical problems and provide analytical recommendations.

Basic Qualifications

• Bachelor's Degree and 6+ years of relevant experience OR Master's Degree and 4+ years of relevant experience OR PhD or PharmD and 0+ years of relevant experience

Preferred Qualifications

• Degree in chemistry, biology, or a related scientific discipline.
• Pharmaceutical or biotechnology industry experience.
• Strong hands-on experience in analytical method development, optimization, and troubleshooting.
• Experience with liquid chromatography, gas chromatography, Karl Fischer analysis, or related analytical techniques.
• Experience conducting stability, stress, and degradation studies.
• Knowledge of impurity assessment and control, including process-related impurities, mutagenic and potentially mutagenic impurities, and nitrosamines.
• Experience applying Quality by Design, Design of Experiments, or Method Operable Design Region principles.
• Experience supporting the development and characterization of solid oral, parenteral, or combination products.
• Ability to independently define analytical approaches and address complex laboratory and development challenges.
• Strong scientific judgment and data interpretation skills.
• Ability to collaborate effectively across analytical disciplines, functions, and organizational levels.
• Ability to begin contributing to hands-on laboratory activities with limited onboarding.