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US-Bothell-Washington: Associate Director, Bioassay Development

Date: 14-May-2013
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Associate Director, Bioassay Development

Lead bioassay development and manage a group of scientists Develop and qualify robust bioassays for antibody drug conjugates in support of QC release and stability testing, product characterization, process and formulation development Interact with research and development groups on a scientific and strategic level Interpret and present data to appropriate stakeholders Participate in cross-functional project teams to evaluate critical quality attributes of antibody drug conjugates and recommend control strategy Author and review sections for regulatory filings, and draft responses to regulatory questions Develop neutralizing antibody assays for characterization of human immune response to therapeutic antibody drug conjugates Provide guidance in technology advancement and mentor scientific staff

PhD in life sciences minimum 10 years industry experience in biologics development Hands-on proficiency with cell-based assays (binding, cytotoxicity, effector functions, etc.) Excellent understanding of current industry best practices and regulatory guidance for potency assays Knowledgeable in statistics required for potency analysis Ability to motivate others and deliver in a timely manner Ability to think strategically and adapt to changes quickly Strong ability to multi-task in a fast-paced environment Demonstrated ability to communicate professionally and diplomatically Strong managerial, organizational and interpersonal skills Ability to present in a concise and impactful manner Experienced and knowledgeable in GMP regulations Demonstrated ability to operate independently and in team settings Experience in immunological and biological characterization of antibody products a plus Regulatory experience in addressing bioassay questions for early and late stage products highly preferred

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