The Opportunity
We have an exciting opportunity available for a Compliance Scientist to join the Research and Clinical Bioanalytics (RCB) Department in Pasadena, CA. In this role, you will ensure appropriate compliance and quality standards are set, applied and maintained in the planning, organization, co-ordination and day-to-day operation of the research, development and validation of regulatory compliant bioassays and biomarkers to support R&D projects from Stage Gate 1 (SG1) through to all stages of Clinical Development. The successful incumbent will:
- Support RCB's growing compliant laboratory operations and documentation processes to enable delivery of appropriately compliant bioassays and biomarkers with associated reagents to measure the pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of biologic therapies in research, GLP toxicology and clinical development studies,
- Ensure that work is conducted according to the specific requirements of GCP/GCLP standard
- Be trained in the conduct of the assays, to both enable better appreciation of the compliance requirements of the processes involved and to allow participation in assay campaigns when required
Skills and Experience Required:
- A MS/PhD in a scientific/medical/(bio)pharmaceutical discipline
- At least 3 years' experience in pre-clinical and clinical development of biopharmaceuticals or equivalent related experience in industry and/or academic environments
- Experience in writing SOPs, Forms, Scientific/Validation protocols and reports
- Experience of working in a compliant Laboratory environment
- Relevant and demonstrated expertise in the following:
- In vitro assays (e.g. ELISA, electrochemiluminescence [ECL], multiplex assays [MSD, Olink], flow cytometry [cell phenotyping and receptor binding/occupancy]), and the associated instrumentation and software
- Experience in molecular biology [dd/qPCR, primer design,…] is a plus
- Proficient in Microsoft Office and graphics programs (e.g. GraphPad Prism, Visio)
- Very good communication and networking skills. The ability to work successfully in a cross-functional, multidisciplinary and multinational team environment.
