Senior Associate/Manager, Quality Control - Coherus BioSciences

Title:                     Sr. Associate/Manager, Quality Control                 
Reports To:         Senior Manager, Quality Control               
Location:             Redwood City, California
Classification:    Exempt 

Overview:

Coherus BioSciences is seeking a highly motivated and experienced QC professional to provide technical and operational support to Coherus QC. Prior experience in QC overseeing in-process, lot release and stability testing as well as strong understanding of the analytical and bioanalytical methods used for testing of Biologics is required. This is an individual contributor role with potential for having a direct report depending on past experience.

This individual will work in a matrixed environment partnering with internal teams and contract organizations to ensure on time delivery of CoAs in support of batch release and stability testing timelines.

Knowledge and proficiency with US and multinational regulations is required. Experience supporting commercialization and lifecycle management activities as well as experience authoring and reviewing relevant sections of the associated regulatory submissions is preferred.

Responsibilities:
Note:  The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

• Manage contract laboratories
• Compile and review contract laboratory analytical data
• Generate Certificates of Analysis (COA) for lot release
• Author or update QC SOPs, protocols, and specification records supporting testing activities
• Review and trend data and support data inputs to Quality Program Reviews (e.g. PQR, QMR, AR, APQR)
• Execute responsibilities in accordance with internal procedures
• Lead and support lab investigations, deviations, CAPA implementation, and change control activities in support of QC operations
• Evaluate and continuously improve QC systems and procedures to ensure compliance with current regulations
• Interface with the analytical team, QA, Operations and Regulatory to execute Coherus’ operational plan
• Monitor lab performance via key metrics and partner with internal and external stakeholders to improve performance
• Assure qualification and validation status of lot release and stability indicating methods
• Author and/or review relevant sections in regulatory submissions
• Support specification development and revision as required
• Support contract organization and vendor audits as required
• Own POs and monitor external expenses supporting routine testing operations
• Up to 20% Travel as necessary to support organizational activities

Qualifications:

• BS/BA in chemistry, biology, or a related field is required; an advanced degree is preferred.
• A minimum of 5 years in a GMP environment (pharmaceutical or biopharmaceutical industries) with at least 3 years in a QC laboratory overseeing QC operations
• Familiarity with cGMP and muti-national regulations and guidances related to pharmaceutical and biotech products
• Familiarity with statistical analyses related to pharmaceutical / biotech drug product testing and stability monitoring including familiarity with statistical software programs
• Previous experience is preferred in QC lab or QC stability program in a pharmaceutical or biotech environment
• A well-rounded technical background encompassing analytical methods, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and/or thermodynamics is required
• Familiarity with biopharmaceutical production and testing is required
• Proficiency with performing root cause analysis in support of lab investigations and manufacturing deviations
• Ability to solve complex technical problems
• Excellent written and communication skills, scientific report writing
• Strong computer skills including proficiency with statistical analysis software is desired