Associate Director, Antibody Analytical Sciences (Bioassay)

Responsibilities

• Responsible for broad analytical aspects of Arcus’ antibody programs with emphasis on bioassays and immunoassays.
• Ensure robust bioassay/immunoassay method development and validation, leveraging internal and external (CMO/CRO) resources.
• Provide broad technical inputs for method development and implementation supporting process and product design including control strategy definition, product characterization, specification setting, and establishing stability and comparability strategies to enable successful regulatory submissions
• Partner with several other functional areas (e.g., Development, Manufacturing, Clinical, Quality, Regulatory, etc.) to ensure that our antibody development and manufacturing activities are always aligned with the highest quality standards (including cGMP compliance) and overall corporate objectives

Qualifications

• Ph.D. in Biochemistry or related discipline such as Biological Science, Biotechnology, Chemical or Biochemical Engineering with 7+ years of biotechnology/pharmaceutical industry experience or M.S. with 9+ years of experience or B.S. with 11+ years of experience
• Deep understanding of the principles of antibody structure and function, the molecular and biological characteristics that determine their properties and utility as human therapeutics as well as various analytical techniques to measure and quantify these attributes
• Strong knowledge of biopharmaceutical analytical development for antibody drug substances and drug products
• Strong understanding of GMP requirements and regulations for clinical and commercial CMC drug development
• Technical leader with extensive experience in cell-based bioassay/potency assay and other analytical methodologies
• Proven track record in phase-appropriate analytical method development, qualification and validation for drug substance and drug product
• Experience in setting GMP specifications, control strategies, stability studies, and comparability from early phase to commercialization
• Excellent knowledge of all regulatory guidelines relevant to GMP work. Experience in all phases of regulatory expectations, submissions and interaction with US and international regulatory authorities
• Experience in managing analytical development activities at CROs and CMOs
• Strong aptitude to think strategically, with excellent analytical, problem-solving skills
• Excellent communication, presentation and writing skills, including extensive experience authoring technical reports and regulatory documents as well as responding to agency questions (RTQs)

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3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer