Responsibilities
• Represent Bioanalytical function on clinical Study Management Teams, contributing to defining operational strategies and plans, and successful execution of clinical studies.
• Serve as an interface between Arcus and external CRO collaborators, developing productive relationships and leading efforts to achieve optimal efficiency in external workflows to ensure delivery of PK and immunogenicity testing data within timeline.
• Partner with Bioanalytical Scientists on managing method transfer, method validation and sample analysis at CROs in line with scientific principles and global regulatory standards for quality and compliance, including applicable GxP principles.
• Manage budget proposals and invoices.
• Coordinate with other Arcus Biosciences groups to manage the synthesis, characterization, and supply of reference materials, critical reagents, and related materials required by CROs to conduct regulated bioanalytical work.
Qualifications
• BS or MS degree in analytical chemistry, pharmaceutical sciences, biology or related field with relevant experience (10+ years for BS, 8+ years for MS) in biopharmaceutical industry.
• Experience in bioanalytical method development, validation and sample analysis in support of drug development process.
• Familiarity with regulatory guidelines and GxP principles.
• Knowledge of techniques associated with collection and analysis of biological samples for analytes of interest using various techniques.
• Technical understanding of bioanalytical operations, including sample analysis strategies, instrumentation, and general laboratory operations.
• Basic understanding of factors affecting the precision, accuracy, and reliability of bioanalytical assays, including the mathematical treatment of data from such methods.
• Demonstrated ability to work effectively and collaboratively on cross-functional teams, managing workflows and timelines with organizational savvy.
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
This role can be based at our Hayward, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $120,000 - $160,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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