Assist in the development, validation, and transfer of stability testing programs, as directed by senior lab personnel.
Document and record test results, observations, and data accurately and in a timely manner.
Assist in conducting routine stability testing of raw materials, intermediates, and finished products under the supervision of senior team members.
Prepare samples, reagents, and solutions for analysis, following established protocols and procedures.
Support the execution of stability studies, including sample preparation, monitoring, and documentation.
Support stability testing activities to assess the shelf-life and performance characteristics of products.
Assist and perform basic calibration and maintenance of laboratory instruments and equipment, ensuring proper functionality and accuracy.
Document and record test data, and assist in the preparation of reports.
Follow standard operating procedures (SOPs) and safety protocols to maintain a safe and clean working environment.
Maintain a clean and organized laboratory environment, adhering to safety guidelines.
Follow established protocols and procedures to ensure accurate and reliable results.
Stay updated with regulatory changes, the latest stability techniques and technologies through continuous learning and training opportunities.
Collaborate closely with cross-functional teams, including Research & Development, Quality Assurance, and Manufacturing, to drive alignment, coordination, and shared responsibility for product development, quality, and continuous improvement initiatives.
Contribute to continuous improvement initiatives within the lab, suggesting ideas and implementing best practices.
Skills Competencies And Qualifications
Knowledge of regulatory guidelines (e.g., FDA, EMA) and industry best practices related to analytical development and stability testing.
Basic knowledge of laboratory safety practices and procedures.
Knowledge in analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.
Familiarity with statistical analysis software and data management systems.
Familiarity with regulatory requirements and quality standards related to analytical development and stability testing is a plus.
Good communication and interpersonal skills, with the ability to work effectively in a team environment.
Good English communication skills, both written and verbal. Other languages are a plus.
Excellent organizational and time management skills, with the ability to prioritize tasks.
Strong attention to detail and the ability to follow instructions accurately.
Good computer skills, including proficiency in MS Office applications.
Enthusiasm for learning, adapt to changing priorities, and contribute to a positive and dynamic work culture.
Desire to develop a career in analytical development and lab stability.
