Analytical Development Principal Scientist

Analytical Development Principal Scientist

Job Description

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). This role performs complex analytical testing using advanced instrumentation, supports method development and tech transfer activities, and collaborates closely with development and quality control teams to ensure data integrity and regulatory compliance.

The Principal Scientist also mentors other chemists, contributes to continuous improvement initiatives, and plays a key role in scaling processes to commercial manufacturing within a regulated CDMO/CRO environment.

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.

Essential Skills

+ 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.

+ 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).

+ Demonstrated ability to transfer analytical processes and methods to commercial scale manufacturing settings.

+ Excellent verbal and written communication skills, with the ability to clearly present technical data and collaborate across diverse teams.

+ Strong interpersonal and organizational skills, with the ability to work effectively in a diverse, cross-functional team environment.

+ Proven ability to maintain high standards of data integrity, documentation accuracy, and regulatory compliance.

Additional

Skills & Qualifications

+ Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab 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,…