Associate Director / Director Immunogenicity Assessment
AstraZeneca

Associate Director / Director Immunogenicity Assessment

At AstraZeneca, we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do!

As Associate Director / Director of Immunogenicity Assessment you will be a member of the Integrated Bioanalysis team delivering Immunogenicity assessment strategy, scientific oversight, and regulatory interactions and submissions for AstraZeneca biologics including new modalities subject to preclinical and clinical studies, with focus on bioanalytical strategy, method development and validation, GxP Bioanalysis and Regulatory submission.

Position Responsibilities:

• Lead immunogenicity risk assessment, data analysis and interpretation, ADA assay development, validation and bioanalysis for all biotherapeutics including new modalities.
  
• Review and approve bioanalytical data and reports to ensure quality and integrity. Contribute to regulatory document preparation including integrated summary of immunogenicity (ISI), regulatory responses and submissions.
  
• Work closely with clinical and bioanalytical teams and contribute to the immunogenicity assessment and bioanalytical strategies.
  
• Supervise transfer and validation of developed neutralizing ADA assays to CROs. Work closely with outsourcing team to ensure high quality and timely delivery for the method setup and sample analysis.
  
• Stay current on the immunogenicity assessment and neutralizing ADA assay techniques. Propose and implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements.
  
• Establish internal and external influence through initiatives, consortium activities, presentations, and publications.
  
• Hire and retain talent, develop junior scientists in scientific and professional growth.
  
• Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulation.
  

Associate Director requirements:

• PhD in Immunology, Biochemistry, or related discipline
  
• 3+ years of immunogenicity assessment experience in the pharmaceutical industry or CRO.
  

Director requirements:

• PhD in Immunology, Biochemistry, or related discipline
  

• 15+ years of immunogenicity assessment and regulatory submission experience in the pharmaceutical industry or CRO.
  

Essential Skills:

• Strong experience with the development and validation of immunogenicity assays including ELISA, MSD as well as cut point analysis with the knowledge of current industry practices and regulatory guidance.
  
• Experience with immunogenicity assessment strategies, integrated summary of immunogenicity and document preparation for regulatory submissions.
  
• Experience with complex biologics with multiple domains and new modalities.
  
• Experience managing individual contributors.
  
• Laboratory experience with GLP regulations, GxP documentation and regulatory guidance.
  
• Detail oriented, good documentation practices, technical writing and verbal communication skills.
  
• Ability to handle multiple projects and/or tasks in a fast-paced environment.
  
• Familiarity with spreadsheet, word processing, and graphical computer programs.
  

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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