Job Summary:
Key Responsibilities:
2. Method Development: Develop and validate complex analytical methods for the quantification and characterization of active pharmaceutical ingredients (APIs) and excipients.
3. Quality Control: Lead and conduct rigorous quality control testing to maintain the high standard of pharmaceutical products, ensuring compliance with industry regulations and guidelines.
4. Instrumentation: Manage and maintain analytical instruments, ensuring calibration, troubleshooting, and efficient operation to generate precise and reliable results.
5. Data Analysis: Analyze and interpret complex experimental data, troubleshoot issues, and provide comprehensive reports. Maintain detailed records of experiments and findings.
6. Regulatory Compliance: Stay current with pharmaceutical regulations, such as FDA and ICH, and ensure all analytical procedures and documentation meet the highest standards of compliance.
7. Mentorship: Provide guidance and mentorship to junior Analytical Chemists, assisting with their professional growth and development.
8. Collaboration: Collaborate with cross-functional teams to deliver analytical support for research and development projects, facilitating innovative solutions and product improvements.
Qualifications:
2. 7-10 years of experience in Analytical Chemistry, with a substantial background in the pharmaceutical or a related industry.
3. Proven expertise in analytical techniques, particularly HPLC, GC, and spectroscopy.
4. Demonstrated success in method development and validation for pharmaceutical applications.
5. Thorough knowledge of regulatory guidelines, such as FDA and ICH, with a history of regulatory compliance.
6. Strong problem-solving skills, meticulous attention to detail, and the ability to manage complex analytical challenges.
7. Excellent communication skills, both written and verbal.
8. Team player with strong leadership qualities and the ability to collaborate effectively.
9. Proficiency in data analysis software and laboratory information management systems (LIMS).