Senior Manager, Quality Control, Biologics

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

💊 Pharmazie

🏥 Gesundheitswesen

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.

Beschreibung

• Execute and support QC activities across CDMOs and contract testing labs within a virtual operating model • Ensure all analytical testing for biologics drug substance and drug product meets cGMP, regulatory, and company standards • Oversee QC interface with external partners • Support execution of analytical strategy, method lifecycle management, and data integrity • Support global regulatory filings (IND/BLA/MAA) • Coordinate and support QC activities at CDMOs and contract laboratories to ensure alignment with established plans • Review and approve analytical data for in-process, release, and stability testing • Ensure adherence to quality agreements, regulatory requirements, and company standards • Track and report CDMO performance using KPIs (on-time release, deviations, right-first-time execution) • Lead method transfer, qualification, validation, and lifecycle management • Execute and monitor methods to ensure robust, phase-appropriate, and compliant • Provide technical leadership for investigations, troubleshooting, and assay optimization • Support comparability strategies, method improvements, and continuous verification through data analysis and evaluation • Perform independent review of analytical data, CoAs, and trend reports • Support batch disposition decisions in collaboration with QA • Ensure ALCOA+ data integrity across all partners • Review and approve deviations, OOS/OOT investigations, CAPAs, and change controls • Ensure compliance with cGMP, ICH, USP/EP, and global regulatory standards • Oversee stability programs at CDMOs, including data review, trending, and shelf-life justification • Support audits, inspections, and vendor qualification activities • Support QC contributions to IND, BLA, MAA, and lifecycle submissions • Author and review Module 3 (CMC) sections, ensuring alignment with regulatory expectations • Support preparation of submission-ready documentation, analytical methods, specifications, validation, and comparability strategies • Coordinate CDMO data packages to ensure audit-ready regulatory submissions • Support health authority interactions, including responses to queries and pre-approval inspections (PAIs) • Contribute to post-approval lifecycle activities (supplements, variations, annual reports) • Partner with Analytical Development, QA, Regulatory Affairs, CMC, and Supply Chain to align QC strategy with development and commercialization goals.

🎯 Anforderungen

• Ph.D., MS, or BS in Biochemistry, Molecular Biology, Biotechnology, or related field • 8-10 years of experience in biologics QC, Analytical Development, or Quality • Strong experience working in a virtual biotech/pharma model managing CDMOs and contract labs • Proven track record supporting global regulatory filings and inspections • Extensive experience with IND, BLA, MAA, and post-approval submissions (PAS, CBE-30, variations, annual reports) • Demonstrated expertise in Module 3 (CMC) authoring and analytical control strategies • Strong knowledge of analytical methods, validation, comparability, and stability requirements • Ability to integrate data from multiple CDMOs into cohesive, audit-ready submission packages • Experience responding to health authority queries and supporting pre-approval inspections • Strong focus on data integrity, traceability, and inspection readiness.

🏖️ Vorteile

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits