Arcus Biosciences Careers

Description

Job Responsibilities:

• Responsible for all supply chain related quality activities of Arcus’ antibody and small molecules programs
• Responsible for quality oversite at clinical packaging, labeling, and 3PLsites.  This includes lot genealogy and traceability of labeled clinical kits/product and disposition of Finished Goods
• Responsible for managing temperature excursion and product complaints related to packaging and logistics.
• May be involved with QP related interactions such as establishing QP to QP quality agreements, coordinating QP audits with Arcus Compliance Group, obtaining documents such as Letter of Access.
• Partner with several other functional areas (e.g., Quality Operations, Clinical Quality, CMC Regulatory, Supply Chain, Analytical Sciences, etc.) to ensure that clinical supplies are always available to patients across all programs (antibody and small molecules) and ensure that supply requirements are always aligned with development and manufacturing activities.
• Monitor performance metrics and drive continuous improvements of CMO processes.
• Manage logistics and packaging process related deviations, CAPAs, and change controls.
• Identify, as needed, areas of improving process and procedures in area of responsibility.
• Other duties as assigned.

Qualifications (including knowledge & skills):

• 10+ years of pharmaceutical industry experience in Quality Assurance with direct experience in working with and supporting clinical supply operations.
• Solid understanding of clinical supply chain and logistics
• Solid understanding of EU Qualified person requirements
• In depth understanding and knowledge of US, EU, CN, AU, JP quality requirements.
• Experience in working with external partners and / or contract manufacturing organizations.
• Solid understanding of quality principles, concepts, industry practices, and standards.
• Ability to work independently, a self-starter, and hands on.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to interact with all levels of Arcus employees.

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $173,000 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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