Associate Director, MSAT – Analytical Sciences, Biologics

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🕒 Junho 29

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• Lead the analytical sciences function within MSAT to ensure robust support for commercial manufacturing of biologics (e.g., mAbs, fusion proteins) • Drive analytical control strategy, specification setting, and lifecycle management in alignment with QbD principles • Oversee method performance monitoring and trending, analytical capability assessments, and continuous improvement initiatives • Provide analytical subject matter expertise (SME) during technology transfers to external manufacturing sites • Support manufacturing investigations by leading root‑cause analyses, interpreting analytical data, and defining corrective and preventive actions • Guide method troubleshooting, resolution of OOS/OOT trends, and process–product linkages (CQA–CPP relationships) • Lead analytical method qualification/validation strategy to meet Phase‑appropriate and commercial requirements • Author, review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency queries) • Partner with QA, Regulatory, and MSAT to ensure compliance with global regulatory guidelines (ICH Q2, Q6B, Q14, etc.) • Partner closely with Process Development, Quality Control, Quality Assurance, Regulatory teams • Drive analytical readiness for tech transfers, PPQ readiness, comparability assessments, and lifecycle changes • Lead external oversight of CDMOs/CROs, ensuring analytical deliverables, timelines, and quality expectations are met • Ensure data integrity and proper scientific documentation across MSAT analytical activities

🎯 Requisitos

• PhD or MS in Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related field • 8 + years (PhD) or 12+ years (MS) of experience in analytical development, QC, or MSAT for biologics • Demonstrated technical expertise in analytical methods for biologics (e.g., HPLC/UPLC, CE, LC‑MS, bioassays, ELISA, spectroscopy) • Strong experience in commercial biologics manufacturing support, tech transfer, and method lifecycle management • Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, Q8, Q14; FDA and EMA guidance’s) • Proven leadership skills and experience managing teams or cross‑functional technical groups • Experience with commercial biologics PPQ and BLA/MAA submissions • Expertise in statistical tools (e.g., JMP, Minitab) and digital data systems (e.g., LIMS) • Experience working with CDMOs/CROs and external manufacturing partners • Strong understanding of CQAs, control strategy development, and analytical–process integration.

🏖️ Benefícios

• 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 • Other company provided benefits