About the Role
Our client, a renowned pharmaceutical company, is seeking a highly experienced and innovative Principal Analytical Chemist to lead their analytical development efforts in Sandton, Gauteng . This senior role is critical for the development, validation, and implementation of robust analytical methods to support the characterization and quality control of new drug candidates and commercial products. The Principal Analytical Chemist will be instrumental in setting strategic direction for analytical sciences, mentoring junior chemists, and ensuring compliance with stringent regulatory standards. The position offers a unique opportunity to work with cutting‑edge analytical instrumentation and contribute significantly to the pharmaceutical development pipeline. The ideal candidate possesses a Ph.D. in analytical chemistry, extensive experience in method development and validation for pharmaceuticals, and strong leadership capabilities. This is a premier opportunity to shape the future of pharmaceutical analysis in a dynamic and growth-oriented environment.
Key Responsibilities
- Lead the development, validation, and transfer of analytical methods for raw materials, intermediates, and finished pharmaceutical products using techniques such as HPLC, UPLC, GC, MS, KF, dissolution, and spectroscopy.
- Provide expert scientific guidance and technical leadership to a team of analytical chemists.
- Troubleshoot complex analytical challenges and ensure timely resolution.
- Interpret analytical data, prepare comprehensive reports, and contribute to regulatory submissions (e.g., IND, NDA).
- Ensure all analytical activities comply with cGMP, ICH guidelines, and other relevant regulatory requirements.
- Evaluate and implement new analytical technologies and instrumentation to enhance capabilities.
- Collaborate effectively with R&D, manufacturing, quality assurance, and regulatory affairs departments.
- Contribute to risk assessments and impurity profiling studies.
- Stay abreast of current trends and advancements in pharmaceutical analytical chemistry.
Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- A minimum of 10 years of progressive experience in pharmaceutical analytical chemistry, with a substantial portion in method development and validation.
- Extensive hands‑on experience with a wide range of analytical instrumentation, particularly HPLC/UPLC and LC-MS.
- Deep understanding of pharmaceutical regulations (cGMP, ICH guidelines) and their application to analytical method development and validation.
- Proven experience in troubleshooting analytical methods and instrumentation.
- Demonstrated leadership skills with the ability to mentor and guide scientific staff.
- Excellent written and verbal communication skills, with a strong track record of report writing and technical presentations.
- Strong problem-solving, organizational, and project management abilities.
- Experience with OOS/OOT investigations and CAPA implementation.
- Familiarity with QbD (Quality by Design) principles in method development is a plus.
Benefits
- Our client offers a highly competitive executive salary package, including significant base pay, performance bonuses, and potential long-term incentives.
- Comprehensive medical, dental, and vision insurance are provided.
- A generous retirement savings plan and extensive paid time off are included.
- Opportunities for advanced professional development, such as attending international scientific symposia and specialized training programs, are readily available.
- The company provides access to state‑art analytical laboratories and a stimulating, collaborative work environment in Sandton, Gauteng .
- This role offers substantial opportunities for career advancement and leadership within a prestigious pharmaceutical organization.