Senior Manager, Biologics Analytical Development – Bioassay

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Otsuka Pharmaceutical Companies (U.S.)

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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 development, optimization, qualification, and validation of bioassays, including: • Cell-based potency assays • Binding and functional bioassays (e.g., ELISA, MSD, SPR, flow cytometry) • Support development of assay strategies aligned with regulatory expectations for biologics. • Manage assay robustness, transfer, and comparability across product lifecycle stages. • Serve as subject matter expert (SME) resource supporting bioassays activities on cross-functional project teams. • Provide technical input to CMC, Regulatory, Quality, and Process Development functions. • Contribute to assay strategies for IND, BLA/MAA, and post-approval changes. • Ensure high quality and timely delivery of analytical, compliance, and continuous improvement. • Author, review, and approve technical documents including development reports, protocols, validation reports, and regulatory filings. • Provide analytical support and technical input for regulatory submissions and inspections. • Ensure activities are conducted in compliance with GLP/GMP and data integrity standards. • Oversee method transfer to internal QC or external contract testing laboratories (CDMOs/CROs). • Coordinate and oversee outsourced bioassay activities and ensure alignment with project timelines and quality expectations. • Evaluate assay technologies and recommend improvements to enhance assay performance and efficiency.

🎯 Anforderungen

• PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline • 8–10+ years of experience in analytical development for biologics, with strong emphasis on bioassay development • Demonstrated leadership experience managing scientific teams • Experience supporting biologics development activities and contributing to regulatory submissions • Strong hands-on and theoretical knowledge of: • Cell-based assays (reporter gene, proliferation, cytotoxicity, signaling assays) • Ligand-binding assays (ELISA, MSD, ECL platforms) • Potency assay design, qualification, and validation • Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays

🏖️ Vorteile

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