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Posted: Friday, February 23, 2018 12:08 AM

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Job Description:



Who we are:

Coherus Biosciences is a leader in developing and commercializing biosimilar drugs of the highest quality and value. We have a unique combination of intellectual assets, commercial capabilities, global reach and strategic focus required to successfully develop and market biosimilar drugs. Founded in 2010 as a pure-play biosimilar platform company, Coherus is devoted to expanding patient access to these life-changing therapeutics in major regulated markets around the world. Our platform includes world-class capabilities in process science, analytical characterization, protein production and clinical and regulatory development.

Overview:

This qualified individual should have experience with label-free binding assays particularly Surface Plasmon Resonance (SPR) and be familiar with immunoassay techniques for example ELISA for characterization of molecular interactions of biologics. Particularly, this individual should have experience with SPR assays for ligand binding and/or Fc-FcgR or FcRn interactions. The position requires candidate to initiate development, and conduct qualification/validation of quantitative and kinetic SPR assays for Coherus pipeline products in accordance with FDA guidance to demonstrate biosimilarity. The candidate should be detail oriented in protocol design and execution. Experience with SPR, preferably Biacore T200, and/or 8000, is required.

Expectations will also include routine biacore instrument maintenance, writing SOPs/test procedures, reports, and summarizing/presenting data. Additional responsibilities may include presentation of data in internal cross-functional and external meetings, writing reports to support IND/BLA regulatory filings, and supporting collaborations with other groups/sites. In addition, candidate may have to support research needs such as antibody screening from culture media. The ideal candidate will be a critical thinker who keeps up with latest updates in the field, and leverages KOLs expertise for optimal design of experiments and data interpretation.


Job Requirements

Requirements:

• Master's or Ph.D. in chemistry, biochemistry, or related field. Minimum of 3 years' experience for Master degree and a minimum of 1 year experience for Ph.D. in pharmaceutical, biotech, and/or related industry
• A thorough understanding of chemical and molecular interactions, SPR techniques, and immunoassays for in vitro functional assays is a must
• Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills
• Proficient in Microsoft Excel, PRIZM, and/or other statistical tools to critically analyze data
• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements
• Experienced in preparation and characterization of critical reagents and data trending
• Understanding and knowledge of GLP/non-GLP/GMP and other FDA regulatory requirements associated with analytical testing of biosimilar products
• Maintain effective communication with line management
• Works as a team, trusts and respects team
• Candidate must be highly motivated and able to work in a fast-paced environment



APPLY FOR THIS JOB
Contact Person: Ally Dashner
Email Address: adashner@coherus.com
Phone: 6503950154

• Location: Camarillo, CA, Ventura

• Post ID: 158627292 la
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