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Specialist-R&D, Analytical
$ 3,500 - $ 5,000 / month
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Job Description & Requirements:
- Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
- Conduct method validation studies in accordance with regulatory guidelines and internal procedures.
- Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).
- Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
- Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.
- Identify and resolve technical issues related to analytical methods and instrumentation.
- Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.
- Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.
- Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.
- Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.
- Any other duties as assigned by supervisor.
Qualifications and Education:
- Master’s or Ph.D. or Bachelor in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
Experience:
- 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.