Senior Analytical Scientist - Pharmaceutical Development

About the Role

Our client, a renowned pharmaceutical company, is seeking a dedicated Senior Analytical Scientist to bolster their Pharmaceutical Development department in Nelspruit, Mpumalanga . This role is vital for ensuring the quality, safety, and efficacy of new drug products by developing, validating, and implementing robust analytical methods. You will work with a variety of analytical techniques to characterize raw materials, intermediates, and finished products, playing a key role in regulatory submissions. The ideal candidate possesses a strong theoretical background in analytical chemistry and hands‑on experience with modern analytical instrumentation. This is an excellent opportunity to contribute to impactful pharmaceutical research and development within a supportive and innovative environment in Nelspruit , working on projects that directly influence patient health.

Key Responsibilities

• Develop, validate, and transfer analytical methods for the characterization and quality control of APIs and drug products.
• Perform routine testing using various analytical techniques, including HPLC, UPLC, GC, MS, FTIR, UV-Vis, and dissolution testing.
• Analyze and interpret analytical data, troubleshoot method issues, and document findings comprehensively.
• Ensure all analytical activities comply with cGMP, ICH guidelines, and other relevant regulatory standards.
• Write detailed analytical method validation protocols and reports.
• Collaborate with formulation scientists, process chemists, and quality assurance teams to support product development milestones.
• Maintain laboratory equipment, ensuring calibration and compliance with performance standards.
• Contribute to regulatory filings by providing necessary analytical data and documentation.
• Stay updated on new analytical technologies and regulatory expectations in the pharmaceutical industry.
• Mentor junior analytical scientists and technicians.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• A minimum of 7 years of experience in analytical method development and validation within the pharmaceutical industry.
• Expertise in chromatographic techniques (HPLC, UPLC, GC) and their application to pharmaceutical analysis.
• Proficiency with mass spectrometry (LC-MS, GC-MS) and spectroscopic methods.
• Thorough understanding of ICH guidelines, USP/EP pharmacopeias, and cGMP requirements.
• Experience with stability studies and forced degradation studies.
• Strong data analysis and interpretation skills, with experience using analytical software (e.g., Empower, Chromeleon).
• Excellent technical writing and communication skills.
• Ability to work independently and manage multiple projects effectively.
• Experience with Quality by Design (QbD) principles is a plus.

Benefits

• This role offers a competitive salary, bonus opportunities, and a comprehensive benefits package, including excellent health insurance, retirement contributions, and generous paid time off.
• Our client is dedicated to fostering employee growth through continuous training, workshops, and support for professional development.
• The work environment in Nelspruit is collaborative, dynamic, and focused on scientific excellence.
• Join a leading pharmaceutical company where your skills as a Senior Analytical Scientist will be recognized and contribute significantly to bringing essential medicines to patients worldwide.

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