Senior Scientist

Senior Scientist

Job Description

The Senior Scientist plays a key role in developing, validating, and implementing analytical methods to support raw materials, intermediates, and finished products within a GMP-regulated environment. This position focuses on analytical development for active pharmaceutical ingredients, method validation, and complex data interpretation, while collaborating closely with cross-functional teams. The role offers a clear growth path and serves as a stepping stone toward a Principal Scientist position.

Responsibilities

+ Develop, validate, and implement robust analytical methods for raw materials, intermediates, and finished products.

+ Perform analytical testing using HPLC, GC, GC/MS, FTIR, mass spectrometry, and other laboratory instrumentation.

+ Execute and support method development for compound identification, purity assessment, and potency analysis.

+ Collaborate cross-functionally with development, quality control, and process support teams to troubleshoot analytical issues and provide technical guidance.

+ Interpret analytical data, draw scientifically sound conclusions, and document results in technical reports and laboratory notebooks.

+ Ensure strict compliance with GMP, SOPs, and applicable regulatory requirements, including DEA guidelines.

+ Transfer validated analytical methods to Quality Control and Process Support teams, ensuring effective knowledge transfer and documentation.

+ Support sample analysis for development projects and coordinate external testing activities when necessary.

+ Qualify and maintain reference standards, ensuring accurate calibration, traceability, and documentation.

+ Maintain laboratory documentation, data integrity, and document control practices in accordance with GMP standards.

+ Lead investigations related to analytical issues, deviations, or out-of-specification results and maintain timelines for key activities.

+ Author and review technical documents, including reports and protocols, with a high level of accuracy and minimal errors.

+ Draft new standard operating procedures (SOPs) with guidance as needed to support laboratory operations and compliance.

+ Contribute to continuous improvement initiatives to enhance laboratory efficiency, data quality, and analytical capabilities.

+ Support additional laboratory activities as required to meet project timelines and organizational objectives.

Essential Skills

+ Proven experience in analytical method development and validation for raw materials, intermediates, and finished pharmaceutical products.

+ Hands-on expertise with HPLC, GC, GC/MS, FTIR, and mass spectrometry in an analytical laboratory setting.

+ Strong experience in analytical chemistry with the ability to apply fundamental principles to complex testing and data interpretation.

+ Experience in active pharmaceutical ingredient (API) development and analytical development within a CDMO or CRO environment.

+ Demonstrated ability to maintain compliance with GMP regulations and DEA requirements in a laboratory setting.

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Experience with document control and data integrity within a GMP-compliant environment.

+ Proficiency in assay development, method validation, and routine laboratory operations.

+ PhD in Chemistry with 4+ years of relevant industry experience, OR MS in Chemistry with 8+ years of relevant industry experience, OR BS in Chemistry with 12+ years of relevant industry experience.

+ Ability to lead analytical investigations and manage timelines for key project activities.

+ Ability to author and review technical documents, such as protocols, reports, and summaries, with minimal errors.

+ Capability to draft new SOPs with appropriate guidance and alignment to regulatory and quality requirements.

+ Good understanding of cross-functional principles, including organic chemistry and engineering, to effectively support interdisciplinary projects.

Additional

Skills & Qualifications

+ PhD in Chemistry with 4+ years of relevant industry experience, MS in Chemistry with 8+ years of relevant industry experience, Or BS in Chemistry with 12+ years of relevant industry experience

+ Experience working in contract development and manufacturing (CDMO) or contract research (CRO) organizations.

+ Familiarity with Active Pharmaceutical Ingredient Development and associated analytical requirements.

+ Strong problem-solving skills and the ability to troubleshoot complex analytical and instrumentation issues.

+ Effective collaboration skills to work closely with development, QC, and engineering teams.

+ Attention to detail and commitment to maintaining high standards of data quality and documentation.

+ Interest in career growth with a clear pathway toward a Principal Scientist role.

Work Environment

This position operates in a GMP-regulated analytical laboratory that supports pharmaceutical development and manufacturing activities. The role involves regular use of advanced instrumentation, including HPLC, GC, GC/MS, FTIR, and mass spectrometry, as well as routine handling of…