Assistant Scientist AR&D
Provide analytical development support to the business for problem solving and continuous improvement projects. This will include drug substance and excipient changes, product investigations, updating and where necessary developing new analytical methods as below.
To develop and validate, under supervision, suitably rugged physical and chemical analytical methods that will determine all necessary product parameters including physical characteristics, determination of active, degradation products, preservatives, and, if necessary, volatiles using the most suitable analytical instruments available to the company in compliance with standard operating procedures and international scientific, quality and regulatory standards.
Duties and Responsibilities
• To develop, validate and transfer under supervision, analytical methods (including dissolution) that will adequately determine the necessary product characteristics that will eventually be required to release finished product and to monitor the storage stability of new or current products.
• To perform physical and chemical testing on prototype formulations to determine stability and assign provisional shelf life. All work performed to comply with GLP and where necessary, GMP.
• To update product specifications for additional test methods required by new legislation, additional test methods and formulation or excipient changes.
• To produce validation reports, methods of analysis, COSHH assessments, SOP / Work instructions, and relevant scientific protocols and other reports in a format that can be utilised by other departments.
• To review existing products, processes, and analytical methods, recommending improvements as new techniques become available.
• To participate in the management and introduction of updated products and procedures, including project, planning and team meetings under supervision. Maintaining interdepartmental relationships and positively promote the department and its objectives
• To remain aware of developments within the scientific fields and to ensure all products, processes, and analytical methodologies reflect current best scientific practice.
• Responsibilities will include:
• Lab book Analytical data verification, compliance with procedures, raw documentation for all testing, method validation, CofA’s, instrument logbook entries, balance weight check logbooks, standardized reagent logbooks and equipment calibration reports.
• Initial methodology for prototype formulation testing. Recommendations for excipients for formulations by review of stability data.
Competencies
• Teamworking
• Analytical
• Organisation and planning
• Strong communication skill
Knowledge and Experience
- 0-2 years experience
- Level 6 – Bachelor’s Degree
- Degree in lab based science and proven experience in basic laboratory techniques, housekeeping and safety. Must have previous practical experience of HPLC