Analytical Scientist Extractables and Leachables R&D

Major Duties and Responsibilities 

• Lead Risk Assessments for Extractable and Leachables and Nitrosamines  

• Develop, validate and transfer Extractable and Leachables and Nitrosamines analytical methods.  

• Ensure all testing is performed in accordance with testing schedules. Interpret and present analytical results.  

• Provide support to QC, QA, RA and third parties for product investigations. 

• Prepare documents for regulatory filings (CTD Module 3), conduct experiments and provide data to support responses to regulatory authorities request for information (RFI) 

• Participate in cross functional teams at project-related internal and external meetings, lead or facilitate technical discussions. 

• Maintain interdepartmental relationships and positively promote the department and its objectives. 

• Remain aware of developments within the scientific fields and ensure all products, processes, and analytical methodologies reflect current best scientific practice. 

• Successfully investigate and resolve moderately complex analytical problems, project issues and deviations.  Accurately maintain all related documentation in compliance with written procedures. 

• In conjunction with the Manager, Principal or Senior Analytical Scientist to assist in mentoring/coaching/training and technical development of other members of staff. Where the incumbent has a direct report perform periodic and annual review. 

• Develop, validate and transfer analytical methods that will adequately determine the necessary product characteristics that will eventually be required to release drug product and to monitor the storage stability of new products, without supervision.  

• 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 including documentation and review.  

• Work as part of a multifunctional team to compile risk assessments and foresee potential issues and assist in providing solutions to problems.  

• Undertaking 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 to achieve Quality Objectives. 

• To produce and/or review validation reports, methods of analysis, COSHH assessments, SOP / WRK instructions, and relevant scientific protocols and other reports in a format that can be utilised by other departments, providing relevant feedback on the content and style of documentation to ensure compliance with company and regulatory requirements 

• Support the planning and management of analytical activities in support of early new product development (feasibility, prototype, method development, early compatibility studies, raw material evaluation, COSHH assessments). Attend and present data at project-related meetings, interact with internal and external parties to ensure objectives are met. 

Competencies   

• Ability to work as part of a team 
• Oral and written communication skills. 
• Detail oriented 
• Ability to meet deadlines
• Research skills

Knowledge and Experience 

• Typical Years of Experience- 2-8 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 Extractables and Leachables and/or Nitrosamine RA and analysis and previous development of analytical methods from first principals and method validation.