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We currently have an exciting opportunity available for a Bioanalytical Science Manager to join a global life sciences company based in the Berkshire area.
As the Bioanalytical Science Manager you will serve as the single point of contact for bioanalysis (PK, immunogenicity and biomarkers) usually from the first regulated toxicology study and beyond with involvement of the bioanalytical representative to facilitate knowledge transfer.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Bioanalytical Science Manager will be office based, however the key duties and responsibilities are as follows:
1. Perform the role of study monitor for sample analysis studies ensuring that data meet the regulatory guidelines and intended study outcomes. Contribute to the preparation and review of study protocols, study reports, communication plans, etc. Ensure reports and documents are available in the right format and on time to support regulatory submissions
2. Set and refine bioanalytical strategy in conjunction with key partners (bioanalytical representative, toxicology, DMPK, clinician etc.) within non-clinical and clinical studies.
3. Responsible for troubleshooting technical issues with the support of the method development scientist. You will also provide scientific oversight for bioanalytical assay validation.
4. Monitor and review technical and operational capabilities of CROs through tools such as key performance indicators(KPIs), technical audits (typically once every two years) and clinical communication plans. Ensure operational timelines are clearly communicated to our internal and external partners and that they are consistently met.
To be successful in your application to this exciting opportunity as the Bioanalytical Science Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences or chemistry based discipline. You will be expected to have extensive experience working within the field of regulatory bioanalysis, with at least some of this experience being gained in a highly regulated CRO or pharma / biopharma environment.
2. Extensive knowledge of a range of bioanalytical techniques including LC-MS/MS, immunoassay, flow cytometry and quantitative PCR to support the analysis of pharmacokinetic and pharmacodynamics endpoints (e.g. NCEs, NBEs, ADA and biomarkers).
3. Extensive knowledge of the latest regulatory standards required for GXP studies, including international guidance's published by regulatory agencies such as FDA, EMA. Previous experience managing CROs to ensure appropriate level scientific and technical content is provided in support of programs.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.