About the Role
Our client is a distinguished pharmaceutical company dedicated to improving global health outcomes through the development and manufacturing of innovative therapies. We are seeking a highly skilled Senior Pharmaceutical Analytical Scientist to join our cutting-edge analytical development laboratory located in Klerksdorp, North West . This vital role involves developing, validating, and implementing analytical methods for the characterization of drug substances and drug products, ensuring product quality and regulatory compliance. The ideal candidate will have a profound understanding of various analytical techniques and their application in the pharmaceutical industry. You will play a key role in supporting drug development programs, conducting stability studies, and troubleshooting analytical challenges. This position offers an exciting opportunity to contribute to scientific advancements and career growth within a reputable organization committed to excellence. Our facility in Klerksdorp, North West is equipped with advanced analytical instrumentation.
Key Responsibilities
- Develop, optimize, and validate analytical methods (e.g., HPLC, GC, MS, UV-Vis, KF, dissolution) for raw materials, in-process samples, and finished pharmaceutical products.
- Perform routine testing and analysis of samples according to established methods and protocols.
- Conduct forced degradation studies to understand impurity profiles and degradation pathways.
- Analyze and interpret complex analytical data, preparing comprehensive reports and summaries.
- Troubleshoot and maintain analytical instrumentation, ensuring optimal performance and calibration.
- Support regulatory filings by providing well-documented analytical data and method validation reports.
- Collaborate with formulation development, process chemistry, and quality control teams to address analytical needs throughout the product lifecycle.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Stay current with scientific literature and emerging trends in pharmaceutical analytical chemistry.
- Mentor junior scientists and provide technical guidance on analytical methodologies.
Requirements
- Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field.
- Minimum of 5 years of hands-on experience in pharmaceutical analytical development and quality control.
- Extensive experience with chromatographic techniques (HPLC, UPLC, GC) and spectroscopic methods (MS, NMR, UV-Vis, FTIR).
- Proficiency in method validation according to ICH guidelines.
- Strong understanding of pharmaceutical product development, manufacturing processes, and regulatory requirements.
- Experience with stability studies and impurity profiling.
- Excellent data analysis and interpretation skills, with meticulous attention to detail.
- Strong written and verbal communication skills, capable of presenting technical information clearly.
- Ability to work independently and effectively as part of a collaborative team.
- Experience with various dosage forms (e.g., solid oral, parenteral, topical) is advantageous.
- Must be able to work on-site at our Klerksdorp, North West location.
Benefits
- Our client offers a competitive salary commensurate with experience, complemented by performance-based incentives.
- A comprehensive benefits package includes excellent medical, dental, and vision insurance coverage.
- A robust retirement savings plan with employer matching is provided.
- Employees enjoy a generous allocation of paid time off, including vacation, sick leave, and public holidays.
- Opportunities for professional development, such as attending scientific conferences, workshops, and further training, are actively supported.
- Our client provides access to state-of-the-art analytical laboratories and fosters a collaborative, innovative research environment.
- We are committed to promoting a healthy work-life balance.
- Relocation assistance may be available for highly qualified candidates moving to Klerksdorp, North West .