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 #J-18808-Ljbffr Actalent