Scientist FR&D
Role Purpose
• To develop without supervision, suitable, stable formulations and processes using formulation aids and processing techniques.
• To produce robust, elegant, modern products in accordance with quality and regulatory guidelines.
• To support analytical method development throughout product development.
• To play an active role in system and instrument training to formulation scientists where required. Provides feedback and guidance to others on content and format of documentation in line with department and company procedures/policies.
Key Responsibilities
• To develop robust and stable formulations for new products that comply with the requirements of regulatory and marketing.
• To manage multi-project tasks assigned day-to-day, from initial approval through to successful production scale up, and license regulatory submission (where applicable) and report progress on a regular basis.
• To play an active role in the management and introduction of new products, including project, planning and team meetings.
• Liaise with multiple departments presenting concise, accurate project updates to facilitate new product introduction.
• To produce outline methods of manufacture for production and support technical transfer to production.
• To produce without supervision protocols and reports, to support process development and validation activities (where applicable).
• To produce documentation which ensures that regulatory stability requirements are met.
• To test and develop test methods which characterise raw materials and products, with respect to particle size and rheological properties (where applicable), providing supporting data and reports described above to support MA applications.
• To ensure all work performed complies with GLP, cGMP.
• To keep accurate records of all work undertaken as per internal/external procedures/guidelines.
• To cultivate interdepartmental relationships and positively promote the department and its objectives.
• To participate in cross functional teams at project-related meetings, lead or facilitate technical discussions.
• To recommend improvements to existing products, processes and development systems as applicable.
• To be aware of external developments within the relevant scientific fields and promote new learning’s to reflect up to date best scientific practice / guidelines.
• To provide support for MA applications, providing information for Development Pharmaceutics reports as directed by Regulatory requirements.
• In conjunction with the team leadership, assist in mentoring/coaching/training and technical development of other members of staff.
• Assist team leadership to maintain appropriate GxP and ethical working standards in all aspects of job responsibilities.
• Assist with key department document reviews, providing feedback and guidance to others on content and format of documentation in line with department and company procedures/policies.
• To produce and/or review: COSHH assessments, SOPs / Work Instructions, and relevant scientific protocols and reports in a form that can be utilised by other departments.
Knowledge & Experience Requirements
• GCSE grade A-C in Mathematics and English (or equivalent).
• Degree in Pharmacy or a laboratory based science degree (or equivalent).
• Has proven experience in a variety of laboratory techniques, housekeeping and safety.
• The ability to work independently on multiple concurrent projects.
• The ability to maintain a high quality of documentation, interpret data and prepare technical reports as necessary.
• Good understanding of EU GMP.
• 5 – 6 years relevant experience.