At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

We pride ourselves on making sure that each decision we make puts patient needs first! This mentality means that our people have permission to take the more unusual path. If they can think of a better, smarter way in which we can change lives through science, we want to hear it.

As a member of the growing Bioanalysis Outsourcing global team within the Integrated Bioanalysis department, responsible for scientific outsourcing of regulated bioanalysis projects. Working from one of our main hubs locations at Gaithersburg (MD), Cambridge (UK) or Gothenburg (Sweden) you will support a diverse and exciting portfolio across multiple therapeutic areas with AstraZeneca, collaborating with numerous partners and project teams. You will have an immediate and lasting impact to our pipeline implementing PK, immunogenicity and PD bioanalytical strategy, validation, and sample testing.

What you’ll do

As a critical member of Integrated Bioanalysis department, you will be delivering the scientific externalisation and oversight of AstraZeneca biologics projects subject to toxicology, PK/PD and clinical studies. Your functions will include, but are not limited to, the successful external transfer, and oversight of the development, validation, and implementation of immunoassays/cell-based assays, molecular biology assays, and Target-Engagement assays on multiple platforms for determination of drug in biological matrices, assessment of drug immunogenicity, and measurement of biomarkers at our external vendors in a GLP/GCP environment. This position will also provide internal support for the preparation of regulatory documents for the molecules and studies.

The candidate will have confirmed expertise in multiple technology platforms, and be experienced in the bio-analysis of antibodies, cell and gene therapies, fusion proteins, in vivo expressed biologics, ADCs and peptides. Working closely with all laboratory groups to ensure accurate oversight, regulatory compliance, platform strategy, and external delivery of our biologics pipeline. Additionally, you will develop and drive the bioanalytical strategy, representing the function at project teams and collaborating with partners. May manage a team depending on experience and knowledge.

Essential for the role

• Strong and confirmed background in the development, validation and implementation of immunochemical and cell-based assays to regulatory standards and guidance

• Experience with sophisticated biologics with multiple domains and new modalities and the bioanalytical requirements to support and further drug development

• Significant experience in PK, immunogenicity and biomarker regulated bio-analysis in pre-clinical and clinical trial settings

• Confirmed experience of external bioanalytical vendor and/or sponsor oversight

• Ability to clearly communicate, engage, influence and collaborate.

• Develop and lead bioanalytical strategy and represent the department at project teams

• Review and approve bioanalytical methods, data and reports to ensure quality and integrity. Contribute to regulatory document preparation including integrated summary of immunogenicity (ISI), IND, CTA and BLA regulatory responses and submissions.

• Ability to handle multiple projects and tasks in a fast-paced and engaging environment

• Proven experience to oversee and interpret data analyses

Desirable for the role

• Familiarity with Automation platforms

• Experience in Biologics analysis on LC/MS platforms

• Background in Pharmaceutical and/or Clinical Trial Research

Salary: Competitive with Excellent Employee Benefits

So, what’s next

Are you already envisioning yourself joining us? Good, because we can’t wait to hear from you!

For more information please contact: sharon.macdonald@astrazeneca.com

Additional information

Our Company Values & Behaviours underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

More information about our sites:

• Cambridge, UK

• Gothenburg, Sweden

• Gaithersburg, US

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

Closing Date

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.