Job Title: Senior Scientist

Job Description

The Senior Scientist independently develops, validates, and authors analytical methods for new and existing products, ensuring that all activities follow standard operating procedures and applicable regulations. This role focuses on testing new development raw materials and pilot lot stability samples, creating and executing instrument calibration and qualification methods, and maintaining laboratory instrumentation. The Scientist serves as a technical expert, advising and training personnel on new methods, instrument operation, and data analysis, while ensuring that research and development practices comply with regulatory requirements and internal policies.

Responsibilities

• Independently develop, validate, and write analytical methods for new development and existing products in accordance with standard operating procedures.
• Test new development raw materials and pilot lot stability samples using appropriate analytical techniques.
• Develop, write, and implement instrument calibration and qualification methods for laboratory equipment.
• Calibrate, qualify, and maintain laboratory instruments to ensure accurate and reliable performance.
• Advise laboratory personnel on new analytical methods, instrument operation, and computer-based data analysis.
• Assist in troubleshooting analytical methods, instrumentation issues, and data anomalies, and drive resolution of technical problems.
• Ensure research and development methods, techniques, and testing procedures comply with government regulations and internal policies and procedures.
• Transfer validated test procedures to appropriate laboratory groups, including preparing documentation and conducting training for technology transfer.
• Inspect and review the work of other scientists to ensure compliance with methods, procedures, and quality standards.
• Train personnel in new analytical methods, instrument operation, and computer analysis of data.
• Test finished products, raw materials, and drug product components using established methodologies.
• Review paperwork, software-generated results, and laboratory notebooks for accuracy, completeness, and compliance.
• Provide timely and appropriate feedback on test results and documentation based on established procedures.
• Perform investigational testing to support root cause analysis and resolution of product or process issues.
• Prepare clear and concise reports for management as required or requested, summarizing test results, investigations, and method validations.
• Maintain research and development functions related to new active ingredients, raw materials, and other components.
• Validate test methods for active ingredients, impurities and degradation products, raw materials, preservatives, and solvents using state-of-the-art analytical techniques.
• Assist in the creation and support of new product applications by providing analytical and technical input.
• Perform accelerated and nominal stability testing of new drug products and interpret results to support product development and shelf-life assessments.
• Support quality assurance, internal audits, compliance activities, inspections, and quality control initiatives as needed.

Essential Skills

• Bachelor’s degree in Chemistry with 8–10 years of relevant experience, or Master’s degree in Chemistry with 6–8 years of relevant experience.
• Strong knowledge of contemporary laboratory practices and procedures.
• Proficiency in computer software used in laboratory environments, including LabX, LIMS, Empower, spreadsheet applications, and word processing tools.
• Ability to operate specialized laboratory equipment such as HPLC, FTIR, pH meters, GC, UPLC, LCMS, and UV/Vis spectrophotometers.
• Experience validating analytical test methods for active ingredients, impurities, degradation products, raw materials, preservatives, and solvents.
• Demonstrated ability to develop, write, and implement analytical methods and instrument calibration/qualification procedures.
• Strong organizational skills with the ability to manage multiple projects and priorities effectively.
• Leadership capabilities with experience guiding and inspecting the work of other scientists or laboratory staff.
• Effective teamwork skills with the ability to collaborate across research, development, and quality functions.
• Sound problem-solving skills, including the ability to troubleshoot methods, instrumentation, and data issues.
• Quality-focused mindset with attention to detail in docum