About the Role
Our client, a progressive pharmaceutical company, is looking for a Senior Analytical Development Scientist to join their research and development team in Benoni, Gauteng . This role is crucial for developing and validating robust analytical methods required for drug substance and drug product characterization, quality control, and stability testing. You will lead projects, contribute scientific expertise, and ensure that analytical methods meet regulatory requirements. The ideal candidate will possess a strong background in analytical chemistry, extensive experience with various analytical techniques, and a meticulous approach to scientific rigor. This is an excellent opportunity to contribute to the development of life-saving medicines within a supportive and innovative environment in Benoni .
Key Responsibilities
- Develop, optimize, and validate analytical methods (e.g., HPLC, GC, UV-Vis, KF) for raw materials, in-process samples, drug substances, and drug products.
- Perform characterization studies and stability testing in accordance with ICH guidelines.
- Troubleshoot analytical methods and instrumentation issues, proposing effective solutions.
- Transfer analytical methods to Quality Control (QC) laboratories and provide necessary training and support.
- Author and review analytical development reports, validation protocols, and method validation summaries.
- Stay current with scientific literature, regulatory guidelines, and new analytical technologies.
- Collaborate closely with formulation development, process development, and regulatory affairs teams.
- Ensure all laboratory activities in Benoni comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Maintain laboratory equipment and ensure compliance with calibration and maintenance schedules.
- Mentor junior scientists and contribute to the overall scientific advancement of the department.
Requirements
- Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Chemistry, or a related field.
- Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
- Expertise in a wide range of analytical techniques, particularly chromatography (HPLC, GC) and spectroscopy.
- Thorough understanding of ICH guidelines, regulatory requirements, and quality systems (GLP/GMP).
- Proven ability to design and execute complex analytical studies.
- Excellent scientific writing, communication, and presentation skills.
- Strong problem-solving abilities and a systematic approach to experimentation.
- Ability to work independently and collaboratively in a team environment at our Benoni facility.
- Experience with dissolution testing and solid-state characterization techniques is a plus.
Benefits
- An attractive annual salary of ZAR .
- Performance-related bonus incentives.
- Comprehensive medical, dental, and vision insurance.
- Pension fund and life assurance.
- Opportunities for advanced training and career progression.
- A collaborative and research-focused environment in Benoni .