Scientist/Senior Scientist - Translational and Development Sciences (Bioanalytical)

Company: Coherus Biosciences
Location: Camarillo
Posted on: March 26, 2020

Job Description:

Title:------------------------------ ------Scientist/Senior Scientist - Translational and Development Sciences (Bioanalytical) Reports To:---------- ----Director, Translational and Development Sciences Location:------------------ --Camarillo, CA Classification:-- ----ExemptOverview:The qualified candidate will join the Bioanalytical group in the Translational and Development Sciences team at Coherus in Camarillo, CA and aide in the advancement of Coherus pipeline. This person will be a highly skilled and experienced bench scientist responsible for the development and validation of ligand binding and cell-based assays to support bioanalysis of biologic drug candidates.--These assays may be used for quantitation of drug levels in various matrices (PK assay); characterization of immune responses (Anti-drug antibody [ADA] and neutralizing antibody [NAb] assays), and possibly biomarkers. The candidate will support the transfer of these assays to CROs. In addition, the candidate will be responsible for sample analysis of non-GLP animal studies. Some sample management for clinical study samples may be required. Initial responsibilities for the candidate will be to assist with the setup of a new bioanalytical laboratory function supporting the Coherus pipeline.--Duties will include the development and use of best practices and standardized processes to support a compliant and safe working environment. Additional responsibilities will include presentation of data in internal cross-functional meetings, writing reports, SOPs, and contributions to IND/BLA regulatory filings, and supporting collaborations with other groups/sites. Familiarity with biosimilar development is a plus.Requirements:PhD in Molecular Biology, Immunology, Biology or related field with a minimum of 3 years relevant bioanalytical experience in drug development for the biopharmaceutical industry or MS with a minimum of 6 years or BA/BSc with a minimum of 10 years.A thorough understanding of regulatory requirements for the development and validation of assays to quantitate protein therapeutic levels and characterize the associated immune response (anti-drug antibody and neutralizing antibody assays) using various immunoassay platforms (eg, MSD, ELISA, Gyros, Biacore, etc.). Knowledge of the validation requirements associated with testing of biosimilar products is a plus.Highly experienced in the GLP and GCP requirements for conduct of bioanalytical sample analysis.Highly experienced in tissue culture and cell-based assaysExperience in the preparation and qualification of conjugated biologicsProficient in statistical and graphical tools for analysis and presentation of dataExcellent record keeping abilities using of ELN (electronic lab notebook) to accurately record, analyze, and document analytical data generated in support of regulatory requirementsExperienced in preparation and characterization of critical reagents and data trending is a plusAbility to manage assay transfers to CROsAbility to handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skillsAbility to work independently as well as in a team; trusts and respects teamCandidate must be highly motivated and able to work in a fast-paced environment

Keywords: Coherus Biosciences, Camarillo , Scientist/Senior Scientist - Translational and Development Sciences (Bioanalytical), Other , Camarillo, California