Senior Scientist

Job Description

Job Description

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.
• 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 maintainin