About the Role
Our client, a leading pharmaceutical research and development company, is seeking an experienced Senior Analytical Chemist to join their innovative team, offering a fully remote work arrangement. This critical role involves the development, validation, and execution of analytical methods for drug substance and drug product characterization, quality control, and stability studies. You will play a pivotal part in ensuring the safety, efficacy, and quality of new pharmaceutical products throughout their development lifecycle. The ideal candidate will possess a deep understanding of analytical chemistry techniques, regulatory requirements (e.g., GMP, ICH guidelines), and a proven ability to troubleshoot complex analytical challenges. Working remotely allows for a flexible and focused approach, collaborating closely with formulation scientists, process chemists, and quality assurance teams globally. This is an exceptional opportunity to contribute to life-saving medicines and advance your career in a dynamic and intellectually stimulating pharmaceutical environment, supported by state-of-the‑art remote analytical tools and resources.
Key Responsibilities
- Develop, optimize, and validate analytical methods for small molecules and/or biologics using techniques such as HPLC, UPLC, GC, MS, UV-Vis, FTIR, and dissolution testing.
- Perform routine and non-routine analyses on raw materials, in-process samples, and finished products to ensure they meet predefined specifications.
- Conduct stability studies and analyze data to determine product shelf-life and storage conditions.
- Troubleshoot analytical instrumentation and method-related issues, identifying root causes and implementing corrective actions.
- Write comprehensive method validation reports, analytical procedures, and regulatory submission documents.
- Ensure all analytical activities are conducted in compliance with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
- Interpret analytical data, prepare reports, and present findings to project teams and management.
- Stay current with new analytical technologies, instrumentation, and regulatory trends in the pharmaceutical industry.
- Mentor junior analytical chemists and provide technical guidance.
- Maintain laboratory equipment and ensure proper calibration and qualification.
- Contribute to the development and improvement of laboratory quality systems.
Requirements
- Master's or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a closely related field.
- Minimum of 5 years of hands‑on experience in analytical chemistry within the pharmaceutical or biotechnology industry.
- Proven expertise in method development and validation according to ICH guidelines.
- Proficiency with a broad range of analytical techniques, particularly HPLC/UPLC, LC-MS, and GC-MS.
- Strong understanding of pharmaceutical drug development processes and regulatory requirements (GMP).
- Experience with data analysis software (e.g., Empower, Chromeleon, ChemStation) and statistical analysis.
- Excellent problem‑solving skills and attention to detail.
- Strong written and verbal communication skills, with the ability to document work thoroughly and present findings effectively.
- Ability to work independently and manage multiple projects in a remote setting.
- Familiarity with pharmacopoeial standards (USP, EP) is a plus.
Benefits
- Competitive salary and potential for performance‑based bonuses.
- Fully remote work arrangement offering flexibility and work‑life balance.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and company holidays.
- Retirement savings plan with employer matching.
- Professional development opportunities, including specialized training and conference attendance.
- Access to cutting‑edge analytical instrumentation and software remotely.
- Opportunity to contribute to groundbreaking pharmaceutical research.
- Collaborative and supportive virtual team environment.
- Work on projects that have a direct impact on patient health.