To provide technical management for set up and management of stability studies and associated transfer and validation of analytical methods to external laboratories. The role will involve overseeing method transfer, validation and ongoing sample analysis for analytical methods to control the quality of both Vector and T cell products. The role will involve overseeing, collating, tracking and trending CMO vector characterisation data. The role will also involve coordinating outsourced analytical activities with other groups within PD. Ability to understand and analyse data is essential in additional to good management skills. The role requires a strong background in analytical methods and data management, ideally gained within a GxP environment.
- Managing external stability activities and associated assay transfer and validation
- Reviewing Data
- Preparing Documentation
- Managing Critical Reagents
- Managing outsourcing activities for wider PD group
- Reviewing GMP documentation
Qualifications & Experience
- Degree in biological science
- Extensive experience within GxP laboratories
- Experience designing stability studies
- Extensive in an analytical role
- Experience of managing GxP assays
- Experience designing assay validation
- Experience analysing data
- Experience writing GxP reports
- Knowledge of formal stability study design/analysis
- Knowledge of biostatistics
- Knowledge and understanding of relevant regulatory guidance’s
- Previous experience of managing outsourcing activities including stability
- Experience working within Analytical Development groups
- Experience contributing to regulatory submissions
- Experience of managing multi-functional projects
Skills and Competencies
- Computer literate and ability to familiarise with different IT systems.
- Excellent numeracy and English language skills (both written and verbal).
- Excellent communication skills (both written and verbal).
- Ability to follow protocols.
- Ability to design experiments and studies to address key scientific questions.
- High attention to detail, good time management skills and communication skills.
- Strong team player but with the ability to work independently as well.
- Highly organised
- Proactive with a can-do attitude
- Experience and knowledge using Basic MS office programs
- Experience using advance project management tools – desirable
- Experience and knowledge using statistical software e.g. JMP, Prism – desirable
- Occasional travel within the EU and US may be required