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Start for FreeSaley Harou Kouka
Senior Director Drug Product Operations @Immunovant
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WORK HISTORY
Senior Director Drug Product Operations @Immunovant
Thousand Oaks, CA, US
Provide strategic oversight on CMOs\' Selection and drug product manufacturing, and device assembly at CMOs • Responsible for the design and management of validation studies, protocol development, data evaluation, preparation, and review and approval of study reports to support drug product manufacturing and product regulatory submissions section. • Author and/or review protocols, development reports, batch records, standard operating procedures, and other technical reports to support regulatory filings. • Manage complex investigations where analysis of situations or data requires an in-depth evaluation of various factors for drug product manufacturing operations. • Help with internal resources, partners, consultants, and vendors for all technical operations-related activities • Supports quality and regulatory activities including site inspections, preparation of technical documents for BLA supplements, FDA observations, and all processing-related issues
EDUCATION
University at Buffalo
Doctor of Philosophy (Ph.D.), Chemical Engineering
SKILLS
ABOUT SALEY HAROU KOUKA
At the helm of drug product operations at Immunovant, my focus is on strategically overseeing CMO selection and manufacturing, ensuring every protocol and validation study aligns with our dedication to excellence. My hands-on approach in managing complex investigations and protocol developments has been pivotal for successful regulatory submissions.The translation of strategic goals into actionable plans has been a cornerstone of my tenure, stemming from a rich background in leading commercial drug product development and transfers at AstraZeneca Biologics. Our team\'s collaboration with internal resources has empowered us to maintain the highest standards in drug product manufacturing operations.
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