Senior Manager, Biologics Downstream Development

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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 downstream process development activities for assigned biologics programs under functional leadership • Design, develop, optimize, and characterize purification processes including chromatography, filtration, viral clearance, and UF/DF • Generate data and support for process understanding, CPPs and CQAs, and support development of control strategies • Apply scientific approach to support development and optimization of purification process • Support technical interactions with CDMOs, ensuring alignment with defined development plans • Support definition of downstream work plan and deliverables • Review and approve CDMO-authored documents including development plans, protocols, reports, batch records, deviations, and investigations • Support technical issue resolution with CDMOs, including troubleshooting, root-cause analysis, and implementation of corrective actions • Support downstream process transfers into and out of CDMOs, including authoring and reviewing transfer documentation • Author and contribute to downstream-related sections of regulatory filings (IND, IMPD, BLA, MAA) • Provide technical input to support downstream process for regulatory interactions, responses to agency questions, and inspections • Ensure all downstream activities comply with applicable GMP, regulatory, and internal quality requirements

🎯 Anforderungen

• Bachelor’s degree in Chemical Engineering, Biochemistry, or Biotechnology with 10+ years of experience; OR Master’s with 7+ years; OR PhD with 5+ years of relevant industry experience • Significant expertise in biologics downstream processing (purification, protein sciences) • At least 2-5 years of experience in supervising technical staff • Strong knowledge of cGMP, ICH Q8/Q9/Q10, and data integrity standards • Experience in DoE (Design of Experiments) tools (e.g., JMP), tech transfer, and vendor management

🏖️ 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 • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits