Scientist

AstraZeneca•Gaithersburg, MD

10h•Onsite

About The Position

Join AstraZeneca's In V ivo Discovery Platforms group within the Biologics Engineering department, where we are pushing the boundaries of science to deliver life-changing medicines. Our passion for discovery drives us to explore novel therapeutic approaches across various diseases, including Oncology, Respiratory, Cardiovascular, and Infectious diseases. As part of our collaborative network, you will have the opportunity to engage with new and exciting technologies that are transforming patient care.

Requirements

BS (5+ years) or MS (2+ years) with hands-on experience in animal handling, bioanalysis, pharmaceutical sciences, or a closely related discipline.
Strong background in immunochemical and/or cell-based assays, including experience with cell culture techniques, high throughput flow cytometry, ligand-binding, ELISA, MSD as well as other novel bioanalytical techniques and platforms.
Hands-on experience planning and executing PK in-vivo studies, including animal dosing, sampling, and PK sample handling; understanding of species selection, exposure targets, and PK principles.
Practical experience with PK assay development and qualification (e.g., ligand-binding assays such as ELISA/ECL); familiarity with regulated bioanalysis expectations.
Proficiency with PK data processing.
Strong written and verbal communication skills; demonstrated ability to present PK/bioanalytical results to multidisciplinary teams.
Proven ability to manage multiple studies in parallel, meet timelines, and maintain meticulous documentation in accordance with SOPs and quality standards.

Nice To Haves

Laboratory experience with GxP regulations, documentation, regulatory guidance, and regulatory submission.
Understanding of immunogenicity assessments and their impact on PK; experience with biologics modalities (e.g., mAbs, bispecifics, ADCs, peptides, nucleic acid-based therapies).
Familiarity with spreadsheet, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.) and experience with electronic notebook keeping and data entry using Genedata Biologics.

Responsibilities

Design and execute in vivo studies, interpret pharmacokinetic (PK) data, and develop and qualify PK assays to support discovery programs and novel platform technologies.
Evaluate panels of lead candidates in vivo, deliver high-quality PK datasets, and collaborate closely with cross-functional partners to inform data-driven decision making across programs.
Complete wet-lab experiments (80%) and data analysis (20%).
Design and execute in-vivo PK studies across relevant species; coordinate animal dosing, sampling, and logistics; ensure data integrity and compliance with internal SOPs and applicable guidelines.
Develop, qualify, and, where, validate PK bioanalytical assays fit for purpose across discovery and regulated contexts.
Perform PK sample analysis, troubleshoot assays, and deliver high-quality datasets within agreed timelines; ensure appropriate controls and documentation for traceability.
Collaborate with in-vitro, in-vivo, and bioanalysis scientists to build research plans and align on study designs; present data and recommendations to project teams and department leadership.
Identify opportunities to streamline workflows, implement best practices, and adopt new technologies to improve throughput, quality, and decision speed.
Assist with cell culture, including routine maintenance and expansion.
Work within a matrixed environment across multiple groups.