About the Role
Our client, a prominent player in the pharmaceutical industry, is seeking an experienced Lead Chemist to head their Analytical Development department in Paarl, Western Cape . This crucial role involves the development, validation, and implementation of sophisticated analytical methods for drug substances and drug products. You will lead a team of analytical chemists, oversee laboratory operations, and ensure compliance with stringent regulatory standards. This position operates on a Hybrid model, balancing essential on-site laboratory work and collaboration in Paarl, Western Cape , with flexible remote work opportunities for data analysis and report writing. We are dedicated to fostering scientific excellence and innovation, providing access to advanced instrumentation and a supportive team environment. The ideal candidate will possess a strong background in analytical chemistry, a proven ability to lead teams, and a commitment to quality and regulatory compliance. This is an exciting opportunity to drive analytical strategies and contribute significantly to the pharmaceutical development lifecycle.
Key Responsibilities
- Lead and mentor a team of analytical chemists in method development and validation activities.
- Develop, optimize, and validate analytical methods (e.g., HPLC, GC, MS, UV-Vis, KF) for raw materials, intermediates, and finished products.
- Troubleshoot and resolve analytical issues encountered during development and routine testing.
- Author and review analytical method validation reports, development protocols, and Standard Operating Procedures (SOPs).
- Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulatory requirements.
- Collaborate with formulation development, quality control, and regulatory affairs teams.
- Oversee the qualification and maintenance of analytical instrumentation.
- Manage project timelines and resources effectively within the analytical development group.
- Stay updated on the latest analytical technologies and regulatory trends.
- Present analytical strategies and findings to internal stakeholders and regulatory agencies.
Requirements
- Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Chemistry, or a related field.
- Minimum of 6 years of experience in analytical method development and validation within the pharmaceutical industry.
- Proven experience in leading and managing a team of scientists.
- Extensive hands-on experience with chromatographic techniques (HPLC, UPLC, GC) and spectroscopic methods.
- Strong understanding of GMP, ICH guidelines, and regulatory submission requirements.
- Proficiency in using analytical instrument software and data analysis tools.
- Excellent problem-solving, critical thinking, and organizational skills.
- Strong written and verbal communication skills.
- Ability to work effectively in a fast-paced, team-oriented environment.
- Experience with dissolution testing, impurity profiling, and stability studies is highly desirable.
Benefits
- Our client offers a competitive salary package and performance-based incentives.
- Comprehensive health, dental, and vision insurance are provided, along with a retirement savings plan.
- Opportunities for professional growth, including advanced training and conference participation, are readily available.
- Generous paid time off is standard.
- Our state-of-the-art laboratory facilities in Paarl, Western Cape are equipped with cutting-edge instrumentation, offering an excellent work environment.
- We promote a culture of collaboration, scientific rigor, and continuous improvement.