You will be located at our Gaithersburg strategic hub, where you will work alongside TA leads and stakeholders. You will be expected to contribute directly to AstaZeneca’s leading position driving science and innovation in the field of bioanalysis impacting assets across the portfolio.  This is a key leadership role leading a team of advance scientists providing technical and scientific solution to complex bioanalytical challenges across a wide array of modalities.  You will be expected to have a proven track record as a bioanalytical thought with an outstanding reputation for providing innovative solution in regulatory bioanalysis while ensuring systems are in place to enable data is delivered to the required quality standard.  The successful candidate teak up the role as test facility manager ensuring compliance with regulatory guidance, SOPs and quality standards.  In this highly visible role, you will be required to use your scientific knowledge and expertise to drive the strategic direction of the regulatory bioanalysis group leveraging advanced AI tools.  You will also work with team members to ensure interfaces with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and responding to Health Authority questions.  

Education/Experience required: 

• PhD. or MSc.  With at least 10 years’ experience in a regulatory bioanalytical leadership role. 

Essential for the role: 

• Capable of contributing directly to AstraZeneca leading position in driving science and innovation in the field of bioanalysis 

• Proven ability to lead a team of advanced scientists providing scientific direction and technical input while ensuring on time portfolio delivery 

• Capable of working with staff to maximise their potential and achieve career goals 

• Experience in driving innovative solutions to complex portfolio needs though innovative bioanalytical solutions 

• Actively contribute to driving advancement of Integrate Bioanalysis via impact in leadership teams, partnering with peers and stakeholders 

• Ability to partner with leaders across CPSS and the wider AstraZeneca community to advance portfolio assists. 

• In depth understanding of regulatory submission needs across geographies 

• Proven track record in assessing and developing talent  

• Accountable for ensuring data is delivered on time to the required quality standards 

• Proven ability to act as test facility manager, with expertise in driving, executing and leadership in ensuring compliance with scientific standards and regulatory quality systems  

• Clear understanding of context of use and deployment in developing, validating and utilizing assay to support biomarker analysis needs 

• Proven publication and presentation record 

• Exceptional verbal and written communication skills 

Desirable for the role: 

• Advanced experience in implementing automated AI solutions 

• Internationally recognised bioanalytical thought leader 

• Line management experience 

• Experienced in multiple therapeutic modalities  

• Expertise of multiple analytical methods including but not limed to ligand binding assays mass spectrometry, flow cytometry and techniques to determine immune response  

So, what’s next? 

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