Senior Scientist, Chemistry

Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, and regulatory submission documents Perform investigations and technical troubleshooting Provide documentation and technical input during regulatory and internal inspections and audits Apply working knowledge of data integrity Train staff on analytical techniques and problem solving as needed Influence external sites in the worldwide manufacturing network to identify, implement, and troubleshoot laboratory test methods, workflows, and materials Support compliant, robust, and responsive supply Drive lead-time reduction and efficiency gains supporting World Class Supplier and Operationalizing Quality goals Requirements MS in Chemistry or related discipline with at least 5 years of relevant pharmaceutical development experience, or PhD in Analytical Chemistry or related discipline Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances Strong verbal and written communication skills Flexibility to work in a dynamic environment with internal and external communications Strong interpersonal skills and cultural sensitivity Self-motivated ownership and accountability for issues through completion Ability to adapt quickly to changes and develop risk-management plans Willingness to travel abroad Knowledge of developing analytical techniques such as chromatography and spectroscopy and product specifications for drug substance development and registration Fundamental knowledge of synthetic organic chemistry Working knowledge of API development and commercialization Experience with contract manufacturing organizations and/or contract research organizations Experience working in cross-functional teams Strong technical background, problem-solving skills, leadership abilities, cGMP knowledge, and data integrity knowledge Core Competencies Demonstrates expertise in analytical techniques, including chromatography and spectroscopy, with a strong foundation in synthetic organic chemistry and API development. Proven ability to lead cross-functional teams, ensure compliance with cGMP standards, and effectively communicate technical information. Highest-signal resume keywords Analytical Techniques Chromatography Spectroscopy CGMP Knowledge Data Integrity ATS Optimization Keywords Hard Skills Analytical Procedures Validation Protocols Technical Reports Experimental Designs Regulatory Submission Documents Problem-Solving Risk-Management Plans API Development Drug Substance Development Product Specifications Soft Skills Strong Verbal Communication Strong Written Communication Interpersonal Skills Cultural Sensitivity Self-Motivated Industry Keywords Pharmaceutical Development Contract Manufacturing Organizations Contract Research Organizations Cross-Functional Teams World Class Supplier #J-18808-Ljbffr Jobtailor