- Lead and supervise the analytical method development team in designing, developing, and validating stability indicating methods using HPLC.
- Plan and execute analytical method development projects, ensuring timely completion and adherence to project goals.
- Provide technical expertise and guidance on HPLC and GC to team members and other departments.
- Troubleshoot and resolve technical issues related to HPLC instrumentation and methodologies.
- Ensure all analytical method development activities comply with regulatory requirements and company standards.
- Collaborate with cross-functional teams, including Quality Control, Regulatory Affairs, and Research & Development.
- Prepare and review technical documents, including protocols, reports, and standard operating procedures (SOPs).
- Mentor and train junior staff, fostering a culture of continuous learning and improvement.
- Stay updated with the latest advancements in HPLC, GC and LC-MS technology and methodologies
Bachelor's degree in Science, Pharmaceutical Sciences, or a related field.Experience from (6 : 8) years in analytical method development.Proven track record of successfully leading and managing analytical method development projects.Strong understanding of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).In-depth knowledge and hands-on experience with LC-MS instrumentation and software.Experience with LC-MS analytical method development and validation of N-Nitrosamine impurities.Familiarity with advanced LC-MS techniques and applications .Excellent problem-solving and troubleshooting skills.Strong leadership and team management abilities.Effective communication and interpersonal skills