Analytical Scientist

Barrington James; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Barrington James is seeking an experienced Analytical Development Scientist to join a growing CMC and Pharmaceutical Development team. You will support analytical method development, testing, data interpretation, and lifecycle management across small molecule programs from early development through commercial readiness.

The role emphasizes collaboration with Analytical Development, Formulation Development, Process Chemistry, Quality, and external manufacturing partners, contributing to

Qualifications

• 5+ years of experience in Analytical Development and/or Quality Control.
• Strong understanding of CMC development for small molecule drug development.
• Experience with HPLC and UPLC and related chromatography data systems.
• Experience reviewing analytical datasets and technical reports from external labs/CDMOs.
• Working knowledge of GMP and non-GMP documentation practices.

Responsibilities

• Review analytical data packages from CDMOs and external labs for stability, release testing, and tech transfer.
• Perform analytical testing using chromatographic/spectroscopic techniques.
• Design, develop, optimize, and troubleshoot analytical methods for APIs and excipients.
• Support analytical activities across multiple projects including formulation and process development.
• Generate conclusions and recommendations based on analytical results; communicate to cross-functional teams.
• Participate in stability studies: execution, data trending, interpretation, risk identification.
• Support method transfers and ensure performance verification with internal and external partners.
• Collaborate with Process Chemistry, Formulation Development, QA, Regulatory Affairs, and Manufacturing.
• Author and maintain GMP documentation and test methods.
• Maintain lab compliance and proper documentation, and support investigations of OOS/OOT.

Skills

Analytical method development

Data interpretation

Cross-functional collaboration

Lifecycle management

HPLC/UPLC

GMP documentation

Project management

Analytical data review

Education

Bachelor's degree in Analytical Chemistry or related

Advanced degree (MS or PhD) in Analytical Chemistry or related

Tools

Empower

ChemStation

LIMS

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

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 Analysis)
• FTIR (Fourier Transform Infrared Spectroscopy)
• Residual Solvent Analysis

Additionally, candidates with experience supporting:

• Method transfer and validation activities
• Stability program management
• IND, NDA, or international regulatory submissions
• CDMO oversight and external partner management
• Commercial product lifecycle support

will be viewed favorably.

What We're Looking For

The ideal candidate is a scientifically rigorous and detail oriented analytical chemist who combines strong laboratory expertise with a practical understanding of pharmaceutical development. You are comfortable working both independently and collaboratively, can critically evaluate complex analytical data, and are motivated by the opportunity to help advance innovative therapies through development and commercialization.

You bring excellent communication skills, a proactive mindset, and the ability to build effective partnerships across technical functions and external organizations. Most importantly, you enjoy solving analytical challenges and contributing to the successful delivery of high-quality pharmaceutical products to patients.