Scientist FR&D – Tech Transfer (24 month FTC)
Major Duties and Responsibilities
- 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.
- Pre-production lab manufacturing where required to gain an understanding of the manufacturing process.
- Active lead in manufacturing process development of 3rd party products when coming into Rosemont e.g. if equipment train shows some differences or scale up and scale down is required.
- Active participation in process validation of during tech transfer of 3rd party products
- To play an active role in the management and introduction of products from 3rd party developers and manufacturers, including project planning and team meetings.
- Liaise with multiple departments presenting concise, accurate project updates to facilitate an efficient tech transfer process.
- To produce outline master formulations and 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 physical testing including particle size and rheological properties (where applicable), providing supporting data and reports described above to support license variations as part of the tech transfer process.
- 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 without supervision in cross functional teams at project-related meetings, lead or facilitate technical discussions.
- To provide support for MA applications, providing information for Development Pharmaceutics reports as directed by Regulatory requirements.
- 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.
Standing Operating Procedures
The job holder must remain compliant with Standard Operating Procedures (SOPs). SOPs specific to this job role can be identified via the company Learning Management System and Departmental document control procedures.