As an Executive in Innovative Projects at Sun Pharmaceutical, your key responsibilities will include:
- Handling bioanalytical operations, specifically as a sample processing analyst, with 0-1 year of experience.
- Developing and validating assays for drugs and metabolites in biological matrices.
- Performing analysis of biological samples for development, validation, and assigned projects.
- Operating and maintaining MS/MS instruments to ensure optimal performance.
- Following GLP (Good Laboratory Practice) principles to ensure compliance with regulatory standards.
- Preparing important documents such as Method SOPs, Operational SOPs, Protocols, and Templates.
- Conducting literature surveys to understand and interpret literature for method development, validation, and study sample analysis.
- Recording raw data for method development, validation, and study activities.
- Ensuring laboratory safety and compliance with regulatory requirements, including instrument calibration and logbook maintenance.
- Regularly reporting the status of assigned activities to the reporting manager.
- Continuously improving and maintaining up-to-date knowledge in bioanalytical methods and technologies.
Qualifications:
- A Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or a related field.
- 0-1 year of experience in bioanalytical operations, particularly in sample processing analysis.
- Knowledge of bioanalytical techniques and guidelines, such as those from USFDA, ANVISA, and ICH.
- A strong understanding of bioanalytical assay development and validation processes.
Skills:
- Proficiency in MS/MS instrument operation and maintenance.
- Strong understanding of current bioanalytical guidelines and regulations.
- Ability to perform literature surveys and interpret findings for method development.
- Experience in preparing SOPs, protocols, and reports related to bioanalytical activities.
- Excellent attention to detail and ability to maintain accurate records.
- Strong communication skills for reporting activities and collaborating with team members.
- Familiarity with GLP principles and maintaining compliance with regulatory standards.
