Senior Scientist- Biomarker Evaluation Lab

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Ortho-Clinical Diagnostics, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Biomarker Evaluation Lab located in La Jolla, CA. Ortho-Clinical Diagnostics, Inc. provides in vitro diagnostic products to hospital, commercial and clinical laboratories, and blood donor centers. Its products include reagents and instrument systems used in blood typing and donor testing; clinical chemistry determinations and immunoassays for disease diagnosis and therapy management; as well as RhoGAM®, an injectable drug used to prevent hemolytic disease of the newborn. The Senior Scientist, Biomarker Evaluation Lab will join a diverse, multi-functional organization at J&J referred to as the Pharma Biomarker Support Group (PBSG), dedicated to technology review and new assay prototyping.  The individual will work effectively within the matrixed assay/biomarker evaluation group.  The individual will extensively multi-task and interact with diverse technical groups.  The role of the PBSG is to work closely with pharma discovery and compound development teams to systematically ensure that each compound in the J&J portfolio has a biomarker component as part of the drug development plan, with a clear roadmap (if required) to commercialization of a diagnostic test.  The main focus will be to perform biomarker feasibility studies and prototype assay development geared towards a 'hand-off' to the appropriate J&J diagnostic operating company that will manage commercial diagnostic product development.  In doing so the group is establishing GLP and non-GLP assay protocols and procedures for analyzing clinical samples.  The PBSG will also participate in a broader pharma led effort to establish cross company disease sample banks to enable discovery and validation of novel biomarkers by assembling a strategic collection of clinical samples through acquisition and from internal trials, as well as establishing IT systems for banking, annotation and retrieval.  Finally, the PBSG will assist in select biomarker discovery projects for compounds that are in late development.  The group will thus provide a diagnostic and disease-based perspective in pharma's biomarker discovery, selection and validation processes.   

The minimum requirements for this position are a PhD in Biochemistry or related discipline and a minimum of 3 years experience with protein assay development and validation.  Experience with protein characterization, purification, and modification is required.  Antibody characterization and ELISA development is required.  Antibody purification and modification is preferred.  Experience with cellular-based immunoassays and cellular-based diagnostic assays (e.g. FACS) is preferred.  Experience in developing diagnostic biomarker assays for clinical trials and/or commercialization is preferred.  Extensive experience in developing an effective analyte evaluation plan is required.  Expertise in developing prototype ELISA-based assays is preferred.  A familiarity with diagnostic assay development is preferred.  The individual must quickly understand the unmet biomarker needs associated with diverse therapeutic areas and thus strong project management skills and the ability to multi-task and meet deadlines are required. Excellent written and verbal communication skills are required. An understanding of GLP, QC and QA compliance is preferred.  Ability to analyze molecular entities of various molecular weights and biological origins, post-translational modifications and protein processing is preferred.  Experience with proteomics is preferred.  10 % travel (Domestic) is required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!