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Frederick

    Scientist - Frederick, United States - ClinLab Staffing

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    Description

    Scientist / Sr. Scientist—Frederick, MD

    Responsibilities:


    • Participate and/or lead the development, optimization, qualification, and troubleshooting of analytical methods.


    • Perform analyses of complex data sets.


    • Support implementation of new instrument and evaluation of new instruments/technology.


    • Execute analytical assay methods for routine sample testing to support lot release/stability testing for monoclonal antibody products.


    • Apply technical knowledge and abilities to ensure all testing is performed in a regulatory compliant manner.


    • Participate and/or lead in transfer of methods to Quality Control Group.


    • Author and review STMs, Protocols, and Reports.


    • Mentor junior staff.


    • Performs other related duties as assigned .

    Required Skills/Abilities:


    • Subject Matter Expert for Octet methods to determine kinetics of protein binding interactions.

    o Experience developing novel kinetic methods a plus.


    • Experience in ELISA, qPCR cell-based assays, and/or compendial methods (A280, pH, etc.).


    • Hands on experience in protein analytics including assessment of potency and/or residuals .


    • Strong understanding with method development guidance (ICH, FDA, EMA, USP).


    • Experience with current Good Laboratory Practices (cGLP) and Good Documentation Practices (cGDP).


    • Organized and self-motivated.


    • Experienced in method development and/or qualification.


    • Excellent time management and proven ability to meet deadlines.


    • Excellent communication, presentation, and writing skills.


    • Excellent organizational skills and attention to detail.


    • Excellent time management skills with a proven ability to meet deadlines.


    • Ability to function well in a high-paced and at times stressful environment.


    • Familiarity with Microsoft Office Suite.

    Education:


    • Bachelors, Masters, or PhD diploma in life sciences.


    • At least 7+ years (BS), 5+ years (MS), or 0 years (PhD) of industry, hands-on-experience with development and qualification of characterization/release assays for protein/DNA biological products.



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