AR&D Scientist

Major Duties and Responsibilities

• To develop, validate and transfer analytical methods (including dissolution methodology) 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.
• 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 including documentation and review.
• To produce specifications for new products, review existing products, processes, and analytical methods, recommending improvements as new techniques become available.
• 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 utilized by other departments, providing relevant feedback on the content and style of documentation to ensure compliance with company and regulatory requirements.
• Prepare documents for regulatory filings (CTD Module 3), conduct experiments and provide data to support responses to regulatory authorities request for information (RFI) 5%
• To participate in cross functional teams at project-related meetings, lead or facilitate technical discussions.
• To maintain 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.
• 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 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. 5%

Competencies

• Models the Core Values
•  Holds self and others to a high standard of integrity, treats others with respect and demonstrates responsibility in all actions.
• Healthy Results
•  Sets, pursues and achieves challenging performance targets utilizing behaviours that build trusting, professional relationships
• Inspires the Team Encourage thought, activity or action in others through one’s own words, actions or behaviors.
• Collaboration & Influence Seeks input from others and builds relationships to positively impact performance results.
• Develops Self/Develops Others Approach every experience as an opportunity to continuously learn and share learnings with others.
• Takes Action Forms relationships and proactively takes initiative to improve Rosemont performance and employee engagement.
• Customer Focus Understands and represents the needs and interests of the customer, both internal and external
• Continuous Improvement Continuously improve and enhance processes and performance.
• Planning Develops plans that are appropriately comprehensive, realistic, and effective in meeting goals.

Knowledge and Experience

• GCSE grade A-C in mathematics and English (or equivalent)
• A Level Chemistry (or equivalent)
• Degree in a laboratory based science (or equivalent)
• Has proven experience in a variety of analytical instruments and software utilised for physical and chemical analysis.
• The ability to develop, document and execute analyses or experiments of moderate complexity.
• Must be able to work independently on multiple concurrent projects, develop testing plans that significantly contribute to product knowledge
• The ability to maintain a high quality of documentation, interpret data and prepare technical reports as necessary
• Awareness of laboratory health and safety.
• 5-6 years of relevant experience