We are looking for an Immunogenicity Regulated Project Manager to join our Large Molecule Bioanalysis team.
Senior Scientist/Regulated Project Manager - Immunogenicity
The focus of the team is the development and validation of immunogenicity assays and subsequent analysis of samples to detect antibodies to therapeutic treatments in biological samples. This work is completed within a regulatory framework to deliver high quality analytical data to our clients.
- Experience of performing the role of Study Director/Analytical Project Manager/Principal Investigator for GLP and GCP validation and sample analysis projects
- Immunoassay experience, particularly experience of ADA and nAbs assays. Experience of PK/PD is also advantageous
- Aware of the latest regulatory guidelines for immunogenicity
- You will be skilled at building and maintaining good working relationships with internal and external clients, management and other scientific staff
- You will play an active role in supervising and planning the work of more junior members of the department and contributing to their development and learning
- Experience of managing project timelines and budgets
Education, experience and technical skills:
- Degree in biological science, or relevant experience
- Excellent written and verbal communication skills
- Computer literate
- Experience in a GLP/GCP accredited laboratory
- Ability to work independently as well as part of a team
- Conscientious and meticulous in laboratory work
- Enthusiastic, motivated and driven individual
What we can offer you:
We offer a flexible approach to work, in a friendly and informal environment. As well as a competitive salary, we offer a range of flexible benefits including a group personal pension plan, cycle to work scheme, travel insurance and many more.