To liaise with minimal supervision, with 3rd party product developers and 3rd party manufacturers. to successfully technical transfer (TT) to the receiving unit. To provide Support and Technical expertise to the Quality unit to for the transfer of analytical methods. To ensure analytical methodology is suitably rugged and fit for its intended purpose.
Duties and Responsibilities
• Perform stability testing on Prototype formulations for new drug product developments.
• Develop stability indicating analytical methods (under supervision.
• Validate Analytical Methods including compilation of protocols and reports.
• Work as part of a multifunctional team to compile risk assessments and foresee potential issues and assist in providing solutions to problems.
• Compile Methods and specifications.
• To remain aware of developments within the scientific fields and to ensure all products, processes, and analytical methodologies reflect current best scientific practice.
• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities. · Acknowledge responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.
• Ability to work as part of a team
• Good Oral and written communication skills.
• Detail oriented
• Ability to meet deadlines.
• Research skills
Knowledge and Experience
Typical Years of Experience: 0-2 years’ experience
Minimum Expected Education: Level 6 bachelor’s degree
Additional Information: Degree in Lab based science and proven experience in laboratory techniques. Must demonstrate proficiency in HPLC. Demonstrate aptitude for method development.