Associate Director Integrated Bioanalysis

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!  
 

We are seeking a Associate Director to join Integrated Bioanalysis organization to support Non-GXP bioanalysis and pharmacokinetic/toxicokinetic assessments by LC-MS for critical projects within AstraZeneca portfolio. 
 

Your primary responsibilities will include: 

• Apply state-of-the-art mass spectrometry instrumentation to address sophisticated bioanalytical challenges related to drug discovery and development 

• Development, validation/qualification of LC-MS assays in support of pharmacokinetic (PK), toxicokinetic (TK), Biomarker Quantification in variety of biological matrices 

• Sample analysis for exploratory, GLP and clinical studies using automated and manual sample extraction platforms 

• Perform data analysis on acquired datasets, collaborate with pharmacologists, statisticians, data scientists across global AstraZeneca teams 

• Serve as bioanalytical expert on multidisciplinary project teams 

• Adhere to established Standard Operating Procedures, industry practice and regulatory guidance as appropriate 

• Contribute to validation/qualification protocols and reports, bioanalytical reports, clinical study reports, etc., as appropriate 

• Demonstrate competency in troubleshooting, optimization and implementation of challenging and innovative LC-MS/MS assays 
   

Essential Requirements: 

For Associate Director: 

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related scientific field 

• 7-10 years professional experience 

• Background in analytical (bio)chemistry with emphasis on mass spectrometry applications in at least one of the following: PK of biologics (ADCs or Proteins), biomarker quantification, characterization and relative quantification for impurities/protein PTM 

• Hands-on experience with chromatographic separation, characterization and quantification of various analytes by LCMS. 

• Familiarity with triple quadrupole mass spectrometry instruments, experience with high resolution (HRMS, ToF or Orbitrap) is a plus; 

• Proficiency with mass spectrometry software, data analysis software (Spotfire, R, MATLAB, JMP, etc.) word processing, and graphical computer programs 

• Excellent organizational,  documentation and technical writing skills 

• Excellent command of English (written and oral) 

• Strong communication and interpersonal skills 

• The ability to perform in a fast-paced, matrix-structured work environment. 

• Strong publication/presentation record in analytical (bio)chemistry, bioanalysis, metabolomics/proteomics, or biomarker discovery 

• Significant experience in method development, troubleshooting and complex bioanalytical methods 

• Solid understanding of regulatory guidance on bioanalysis with GxP studies, white papers and industry stan