Principal Scientist Biologics Formulation
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Do you have a strong understanding of protein chemistry and biopharmaceutical formulation development?
Have you had experience of working in a research and development team?
Do you want to work for a company who work together to build a healthier and safer world?
If this sounds like you, we are looking to identify a Principal Scientist to join our client’s growing R&D team within the Chemistry, Manufacturing & Control Department (CMC) in Cambridgeshire.
The Principal Scientist is the company's main contact for their area of expertise. This role requires significant expertise in protein and/or cell and gene therapy formulation, with understanding of early phase biopharmaceutical development.
The overall responsibility of the position is to provide strong scientific leadership in delivering solutions to customers and ensuring flawless execution of projects in the operational area.
As Principal Scientist your main responsibilities will be:
- Rapidly turning around RFI's, proposals (with high level of scientific integrity), and price builds.
- Understanding the way in which drugs are being developed and advise the business on any new developments
- Directing biopharmaceutical development projects
- Providing advice on specific projects (particularly development and validation)
- Advising our study scientists on assay development "troubleshooting" related matters
- Acting as change agents for department change controls and supporting the department as quality investigators to carry out RCA's for deviations, lab investigations and CAPA's
- Developing/providing scientific training modules and materials
- Ensuring a high level of familiarity with the drug pipelines of key customers, including face to face contact
The ideal candidate will have:
- Doctorate (Ph.D) chemistry, biochemistry or a related subject is preferred or equivalent industry experience
- Experience of working in a regulatory environment, ideally GMP/GLP is a distinct advantage
- High level understanding of biopharmaceutical formulation and associated analytical techniques with experience in a developing liposomal and nanoparticulate formulations
- Proficiency in overseeing the design, running and trouble- shooting of assays in the area of expertise
- Be an expert in the area of cell based potency assays
- Strong external and internal scientific credibility