About the Role
Our client, a dynamic pharmaceutical company specializing in Active Pharmaceutical Ingredients (APIs), is looking for an Analytical Development Chemist to join their expanding team in **Queenstown, Eastern Cape**. This role is pivotal in the development, validation, and implementation of robust analytical methods essential for ensuring the quality and purity of APIs. You will work in a modern laboratory, utilizing state-of-the-art instrumentation to characterize raw materials, intermediates, and final API products. The ideal candidate will possess a strong background in analytical chemistry, method development, and validation within the pharmaceutical industry. This position is critical for supporting our client's API manufacturing operations and new product development initiatives. You will be instrumental in upholding the stringent quality standards required in pharmaceutical API production.
Key Responsibilities
- Develop, optimize, and validate analytical methods for the characterization and quality control of pharmaceutical APIs using techniques such as HPLC, GC, UV-Vis, IR, KF, and titrations.
- Perform routine and non-routine analysis of raw materials, in-process samples, and finished API batches.
- Investigate and resolve analytical issues, including out-of-specification (OOS) results.
- Write method development reports, validation protocols, and validation reports in compliance with regulatory guidelines (e.g., ICH).
- Transfer analytical methods to the Quality Control (QC) department and provide training as needed.
- Characterize new chemical entities and impurities.
- Maintain laboratory equipment, ensuring calibration and performance suitability.
- Collaborate with process development chemists, formulation scientists, and regulatory affairs personnel.
- Stay updated on the latest analytical technologies, regulatory requirements, and industry best practices.
- Ensure all laboratory activities are conducted in compliance with cGMP and safety standards.
Requirements
- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 4 years of experience in analytical method development and validation within the pharmaceutical industry, with a focus on APIs.
- Proficiency in chromatographic techniques (HPLC, GC) and spectroscopic methods (UV-Vis, IR).
- Strong understanding of ICH guidelines, cGMP, and regulatory expectations for API analysis.
- Experience with dissolution testing and particle size analysis is advantageous.
- Excellent problem-solving skills and meticulous attention to detail.
- Proficient in data analysis and interpretation, with strong technical writing skills.
- Ability to work independently and collaboratively in a team-oriented environment.
- Familiarity with Quality by Design (QbD) principles in method development is a plus.
- Good organizational and time management skills.
Benefits
- Competitive salary based on experience and qualifications.
- Comprehensive medical aid and retirement fund benefits.
- Opportunities for professional development and advancement within a growing pharmaceutical company.
- Work in a modern laboratory facility in **Queenstown, Eastern Cape**.
- Contribute to the development of critical pharmaceutical ingredients.
- Paid annual leave and sick leave.
- Supportive team environment focused on scientific excellence.
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Analytical Development Chemist - Pharmaceutical API employer: Placements24
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