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.