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

Company: Coherus Biosciences
Location: Camarillo
Posted on: September 1, 2020

Job Description:

Title:------------------------------------Scientist/Senior Scientist - Translational and Development Sciences (Bioanalytical) Reports To:--------------Director, Translational and Development Sciences Location:------------------ Camarillo, CAClassification:------Exempt--Overview:Coherus BioSciences is a leading biologics platform company primarily focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-altering medicines in regulated markets worldwide. Our platform includes world-class capabilities in process science, analytical characterization, protein production, and clinical and regulatory development.We are looking for an energetic and experienced candidate with a desire to work in a fast-paced, fast growing, and dynamic company to support enrichment and advancement of Coherus pipeline products.The qualified candidate will join the Bioanalytical group in the Translational and Development Sciences team at our new lab facility in Camarillo, CA. This person will be a highly skilled and experienced bench scientist responsible for the preparation of critical reagents;--development and validation of immunoassays to support quantitation of drug levels in various matrices (PK assay); development and validation of immunoassays to characterize immune responses (Anti-drug antibodies [ADA] and neutralizing antibodies [NAb]); transfer of these assays to CROs, and monitoring study conduct at CROs. In addition, the candidate will be responsible for sample analysis of non-GLP animal studies.Initial responsibilities for the candidate will be to assist with the setup of a new bioanalytical laboratory 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:Experience in immunoassay development and validation for PK, ADA and NAb assays and analysis of large molecule therapeutics for the biopharmaceutical industry : BA/BS with 10 years; MS with 6 years or PhD with a minimum of 3 years relevant experience.Experience using various immunoassay platforms (eg, MSD, ELISA, Gyros, Biacore, etc.)Experience in the preparation and characterization of conjugated biologics and other critical reagentsExcellent record keeping abilities using ELN (electronic lab notebook)Experience in the GLP and GCP requirements for conduct of bioanalytical sample analysis within a studyKnowledge of regulatory requirements for bioanalytical (PK) and immunogenicity assay validations. Familiarity with requirements associated with biosimilar products is a plus.Ability to manage assay transfers and study conduct at CROsProficient in statistical and graphical tools for analysis and presentation of dataExperience in tissue culture and cell-based assays is a plusExperience in data trending is a plusAbility 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

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