About the Role
Our client, a dynamic and innovative pharmaceutical company, is seeking a highly skilled Senior Analytical Development Scientist to join their cutting-edge research and development facility in Polokwane, Limpopo . This role is critical in developing and validating robust analytical methods essential for characterizing drug substances and products throughout their lifecycle. You will play a key part in ensuring the quality, safety, and efficacy of our client's pharmaceutical pipeline. This hybrid position allows for a blend of focused lab work and collaborative remote engagement, supporting a balanced and productive work environment within Polokwane, Limpopo .
Key Responsibilities
- Develop, validate, and transfer analytical methods for the characterization of drug substances and drug products.
- Utilize a range of analytical techniques, including HPLC, UPLC, GC, MS, spectroscopy (UV-Vis, FTIR, NIR), and dissolution testing.
- Investigate and troubleshoot analytical method issues, ensuring the integrity of results.
- Execute stability studies according to ICH guidelines and prepare comprehensive reports.
- Perform raw material testing and finished product release testing as required.
- Write and review method validation protocols and reports, ensuring compliance with regulatory standards.
- Collaborate closely with formulation development, process development, and quality control teams.
- Stay current with scientific advancements, regulatory requirements, and new analytical technologies.
- Contribute to regulatory filings by providing necessary analytical data and documentation.
- Ensure laboratory operations adhere to cGMP, safety, and environmental regulations.
Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
- Expertise in various analytical instrumentation and techniques relevant to pharmaceutical analysis.
- Strong understanding of ICH guidelines and regulatory requirements for method validation.
- Proven ability to troubleshoot analytical problems and develop innovative solutions.
- Excellent scientific writing skills, with experience in authoring validation reports and SOPs.
- Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
- Effective communication and interpersonal skills for cross‑functional collaboration.
- Experience with Empower or similar chromatography data systems.
- Knowledge of Quality by Design (QbD) principles is a plus.
Benefits
- competitive salary and a comprehensive benefits package, including health insurance, a retirement savings plan, and performance-based incentives.
- Opportunities for professional development, attending scientific conferences, and career advancement are readily available.
- Employees also benefit from generous paid time off and access to company wellness programs.
This role in Polokwane, Limpopo , provides an exciting opportunity to contribute to impactful pharmaceutical research and development within a supportive and innovative environment.