Analytical Scientist

We are seeking an experienced Analytical Development Scientist to join a growing CMC and Pharmaceutical Development team focused on advancing innovative small molecule therapies from early development through clinical and commercial stages. This is an exciting opportunity for a hands-on analytical scientist who thrives in a collaborative environment and enjoys working across Analytical Development, Formulation Development, Process Chemistry, Quality, and external manufacturing partners.

In this role, you will be responsible for supporting analytical method development, testing, data interpretation, and lifecycle management activities while serving as a key technical contributor to CMC development programs. The successful candidate will play a critical role in ensuring robust analytical strategies are in place to support product development, regulatory submissions, technology transfers, and commercial readiness.

• Review, evaluate, and interpret analytical data packages generated by CDMOs and external testing laboratories in support of stability studies, release testing, method qualification/validation, and technology transfer activities.
• Perform analytical testing using chromatographic and spectroscopic techniques to support pharmaceutical development programs, investigations, and characterization studies.
• Design, develop, optimize, and troubleshoot analytical methods for drug substances, drug products, intermediates, and excipients.
• Support analytical activities across multiple projects, including formulation development, process development, process characterization, and control strategy development.
• Generate clear scientific conclusions and recommendations based on analytical results and effectively communicate findings to cross-functional teams.
• Participate in stability studies, including protocol execution, data trending, interpretation of results, and identification of potential product quality risks.
• Support method transfers between internal laboratories and external partners while ensuring successful implementation and performance verification.
• Collaborate with Process Chemistry, Formulation Development, Quality Assurance, Regulatory Affairs, and Manufacturing teams to advance development and commercialization objectives.
• Author, review, and maintain technical reports, analytical protocols, test methods, specifications, SOPs, and other GMP documentation.
• Maintain laboratory compliance through accurate data recording, proper documentation practices, and adherence to internal procedures and regulatory expectations.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), method performance, and laboratory deviations.
• Troubleshoot analytical instrumentation and coordinate equipment maintenance, qualification, calibration, and vendor servicing activities.
• Contribute to continuous improvement initiatives aimed at enhancing laboratory efficiency, method robustness, data quality, and regulatory compliance.
• Assist with preparation of analytical sections for regulatory submissions, technical reports, and CMC documentation as required.

• Bachelor's, Master's, or PhD degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• Minimum of 5 years of experience in Analytical Development and/or Quality Control within the pharmaceutical or biotechnology industry.
• Strong understanding of CMC development activities supporting small molecule drug development programs.
• Proven experience with liquid chromatography techniques, including HPLC and UPLC, as well as associated chromatography data systems and software platforms.
• Hands-on experience developing, optimizing, and troubleshooting analytical methods for pharmaceutical products.
• Experience reviewing analytical datasets and technical reports generated by external laboratories, CDMOs, and contract testing organizations.
• Working knowledge of GMP and non-GMP laboratory environments and associated documentation practices.
• Strong understanding of analytical method lifecycle management, data integrity principles, and laboratory compliance requirements.
• Demonstrated ability to independently manage multiple projects and priorities in a fast-paced development environment.

Experience with one or more of the following analytical techniques is highly desirable:

• Dissolution Testing
• Particle Size Analysis
• Mass Spectrometry (MS)
• XRPD (X-Ray Powder Diffraction)
• TGA (Thermogravimetric…