Scientist III, Analytical Development and Clinical Quality Control

Company: BioCT Innovation Commons
Location: Danbury
Posted on: October 16, 2024

Job Description:

Join our Late Stage Analytical team at Alexion, AstraZeneca, Rare Disease, where you will play a pivotal role in managing development projects through the CMC lifecycle. This position requires analytical experience and the ability to handle multiple projects simultaneously. You will work closely with other PDCS teams, Regulatory, QA and QC laboratories to design the strategy of late-stage analytical activities. This role also involves leading the analytical team from pre-clinical through product launch and authoring for regulatory filing in relevant analytical sections.Accountabilities:As a Scientist III, you will interact with cross-functional teams, lead method transfer/validation activities, drive communications with collaborators, lead troubleshooting and OOS/OOT investigations, review analytical testing procedures, provide subject matter expertise for regulatory interactions, and lead all analytical late-stage activities as analytical functional lead for clinical CMC programs.Essential Skills/Experience:

• MS degree in Biochemistry or related field with 10+ years of Industry experience or Ph.D. degree in Biochemistry or related field with 6+ years of Industry experience.
• Experience in CMC structure and previous experience as project lead for analytical function.
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
• Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.
• Experience in microbiology assays (e.g., required day of harvest, bioburden, endotoxin, sterility and CCIT).
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics.
• Understanding of analytical control strategy and required analytical late-stage activities such as reference standard program, stability program and comparability.
• Ability to work independently to develop and design experiments, critically evaluate data, and then iterate as part of the scientific method.
• Ability to lead investigations and troubleshoot various analytical issues independently with quality and compliance in mind.
• Experience of testing strategy for late-stage program in preparation for BLA filing.
• Excellent written skill for drafting all the GMP related documents.
• Experience authoring regulatory filings and responses.
• Excellent collaboration skills and experience working in cross-functional teams and ability to deliver complex objectives under bold timelines in a rapidly changing environment.
• Extensive experience in compendia methods and multi-country compendia requirements (USP, EP, JP required, CHP preferred).
• Strong direct experience in the development, validation, and transfer of analytical methods for biological products, especially in cGMP environment as listed in ICH Q2.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.
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Keywords: BioCT Innovation Commons, West Hartford , Scientist III, Analytical Development and Clinical Quality Control, Healthcare , Danbury, Connecticut