Analytical Development Principal Scientist

About the role

The Analytical Development Principal Scientist develops, validates, and implements robust analytical methods for raw materials, intermediates, and finished pharmaceutical products, with a focus on small molecule active pharmaceutical ingredients (APIs).

Responsibilities

• Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products, with emphasis on small molecule API development.
• Perform analytical testing using HPLC, GC, GC/MS, FTIR, particle size analysis, and other relevant laboratory instrumentation.
• Execute and support method development for compound identification, purity determination, and potency assays.
• Interpret analytical data, draw scientifically sound conclusions, and document results in detailed technical reports and laboratory notebooks.
• Ensure strict compliance with GMP, SOPs, DEA regulations, and other applicable regulatory requirements in all laboratory activities.
• Transfer validated analytical methods to Quality Control and Process Support teams, ensuring clear documentation and effective knowledge transfer.
• Advise internal and external stakeholders on analytical results, method performance, and technical transfer considerations.
• Mentor and provide technical guidance to other chemists within the department, fostering skill development and best practices.
• Support sample analysis for development projects, including planning, prioritizing, and coordinating external testing when needed.
• Qualify reference standards, maintain accurate laboratory documentation, and uphold data integrity throughout all analytical workflows.
• Maintain robust document control practices within a GMP environment, including assay records, method validation documentation, and quality control data.
• Collaborate cross-functionally with development, QC, and manufacturing teams to troubleshoot analytical issues and support process optimization.
• Contribute to continuous improvement initiatives in analytical development, laboratory operations, and documentation practices.
• Demonstrate the ability to transfer processes to commercial scale manufacturing, ensuring analytical methods are suitable for production environments.
• Participate in additional laboratory and technical support activities as required to meet project and organizational objectives.

Requirements

• Extensive hands-on experience with HPLC, GC, GC/MS, FTIR, and particle size analysis in an analytical chemistry laboratory.
• Strong experience in analytical chemistry and analytical development, particularly for small molecule API and Active Pharmaceutical Ingredient development.
• Proven experience working within a CDMO or CRO environment and familiarity with associated operational and regulatory requirements.
• Demonstrated expertise in GMP-compliant laboratory operations, including document control, assay execution, method validation, and quality control.
• In-depth knowledge of GMP and DEA regulations and the ability to maintain compliance in all analytical activities.

Qualifications

• Ph.D. in Chemistry or related field with a minimum of 8 years of relevant experience, or M.S. in Chemistry or related field with a minimum of 10 years of relevant experience, or a bachelor’s degree in Chemistry or related field with 12 years of experience in a laboratory environment (pharmaceutical experience preferred).
• Experience in API development and small molecule Active Pharmaceutical Ingredient projects within a regulated pharmaceutical environment.
• Experience in method validation, including design, execution, and documentation of validation protocols and reports.
• Familiarity with quality control principles, laboratory best practices, and continuous improvement methodologies.
• Experience coordinating external analytical testing and managing relationships with third-party laboratories.
• Proven ability to mentor junior scientists and chemists, providing technical guidance and supporting career development.
• Strong problem-solving skills with the ability to troubleshoot complex analytical and process-related issues.
• Comfort working within structured document control systems and following established SOPs in a GMP environment.
• Pharmaceutical industry experience is preferred, particularly in development and scale-up of commercial manufacturing processes.