Principal Scientist

AstraZeneca - Gaithersburg, MD - Principal Scientist 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! A Principle Scientist is a member of the Integrated Bioanalysis team delivering bioanalytical strategy, solutions, scientific oversight, and regulatory interactions for AstraZeneca with focus on Liquid chromatography-mass spectrometry (LC-MS) based bioanalytical method development and validation for GxP regulated bioanalysis of mAbs, antibody drug conjugate (ADC) and oligonucleotides in support of preclinical and clinical studies and Regulatory submission as part of development of biologics modalities. Position Responsibilities: Lead to develop LC-MS / MS based bioanalytical capabilities and strategies in GxP setting for quantification / characterization of different biologics in various biological matrices. Lead method development, troubleshooting and validation of LC-MS based assays to support GxP bioanalysis of ADC, payload, metabolites, mAbs, oligonucleotides etc in plasma, urine and various tissues. Develop and execute a bioanalytical strategy as a bioanalytical project lead. Develop timelines and plan / request adequate resources to support critical program activities and meet key deliverables. Prepare method SOPs, validation and sample analysis plans. Analyse data, summarize results and prepare reports. Oversee the transfer and validation of developed assays and sample analysis at CROs. Manage the timelines, deliverables and quality for the data and reports at CROs. Contribute to regulatory documents and response to support various regulatory submission, including IND, BLA Establish internal and external influence through initiatives, consortium activities, presentations, and publications. Develop junior scientists in scientific and professional growth. Maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulation. Ensure that work is conducted in a safe and compliant manner. Essential Requirements: PhD in analytical chemistry, biochemistry or related discipline with 7 or more years' experience in LC-MS of large molecules and conjugates in the pharmaceutical industry or CRO. Essential Skills: Proven expertise in mass spectrometry and chromatographic techniques for the analysis of proteins, oligonucleotides and small molecules. Hands on experience in LC-MS instruments, method development and validation for quantification of mAbs, oligos, ADC, payload and metabolite analysis in various biologic matrices including tissues. Hands on experience on MS data analysis software and data interpretation. Laboratory experience with GLP regulations, GxP documentation, industry practice and regulatory guidance. Experience managing and training junior staff and individual contributors. Detail oriented, good documentation practices, technical writing and verbal communication skills. Ability to prioritize and manage multiple projects in a fast-paced environment. This position is located in Gaithersburg, MD The AstraZeneca Gaithersburg campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross functionally and collaboratively. The Gaithersburg campus also provides an award winning café, free garage parking with electric car charging stations, bike racks, free fitness center to include classed and personal training game rooms, outdoor patio, bocce ball court, arcade games and game tables, recharge Pod's, library, walking trails, onsite dry cleaning pickup, haircutting service, health and wellness center, starbucks café, and much more! 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. 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! Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram... - Permanent - Full-time

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