Associate Director Integrated Bioanalysis at AstraZeneca in Gaithersburg, Maryland

Job Description:

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 standards for bioanalysis
  
  


• Experience serving as functional representative on multidisciplinary project teams with demonstrated ability to communicate complex data effectively to diverse audiences
  
  


• Experience managing/mentoring/supervising junior staff
  
  


• Pharmaceutical/biotech Industry experience
  
  
  

Desirable Requirements

• Pharmaceutical/biotech Industry experience
  
  


• Familiarity with chromatographic assay validation guidelines, GLP/GXP regulations and fit-for-purpose validation principles
  
  


• Experience working in GLP-like/GLP/GMP settings
  
  


• Hands on experience with Sciex MS systems
  
  


• Hands on experience with reverse phase liquid chromatography (RPLC)
  
  


• Experience with protein labelling/LBA assay/magnetic bead based purification
  
  


• Experience with automated/semi-automated sample preparation
  
  


• Protein/ADC/macromolecule mass spectrometry experience
  
  


• Experience in bioanalysis/characterization of antibody-drug conjugates
  
  
  

Benefits:


AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive.



Why AstraZeneca?


At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.


Come and join our journey - Apply today!


The annual base pay (or hourly rate of compensation) for this position ranges from $127,626.40 - $191,439.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.



Where can I find out more?


Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/


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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. Apply Now