202 jobs voor technical leader gevonden


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CMC Analytical leader

time Online sinds 1 september 2023 - Vaste jobs
What will you do? You will work collaboratively with internal stakeholder functions as such as drug substance leader, drug product leader, toxicologist, clinical, project management and regulatory to meet program goals You will ensure all analytical development & stability activities for both drug substance and drug product are aligned with AgomAb projects goals and timelines You will manage analytical development related activities at external vendors, including oversight of method development & validation and stability programs (protocol design, data review, …) You will ensure stability studies support clinical development and regulatory objectives & timelines You will take an active role and apply subject matter expertise in establishing phase-appropriate analytical methods & validation You will oversee qualification of reference materials and management of their inventory & supply across testing sites You will review and approve the analytical related technical documents, including methods development reports, method validation protocols, reports, test methods You will serve as an analytical SME for technical input In collaboration with the drug substance leader and drug product leader : You will determine the retest period & shelf life and specifications of API and drug product You will oversee CDMO analytical deviation & event investigation, and resolution of OOS and OOT testing results You will support analytical in aspects of technology transfer, process scale up, process validation activities at contract organizations You will ensure the integrity of the CoAs You will ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards & guidelines, maintain an understanding of global l laws & regulations applicable to the pharmaceutical industry You will prepare pharmaceutical development reports and other technical documentation required of regulatory submissions including authoring, review and approval of the requisite sections of IND, CTA, IMPD, NDA, MAA or other filings You will assist in the response to health authority questions You will lead and participate in initiatives for improving functional processes and technical operations within CMC .