Associate Director, MSAT - Analytical Sciences (Biologics)

Otsuka Pharmaceutical Co., Ltd.

160d • $169,222 - $253,000 • Onsite

About The Position

The Associate Director of MSAT (Manufacturing Science & Technology) – Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and commercial manufacturing of biologic drug substances and drug products. This role oversees analytical lifecycle management, method qualification/validation, comparability, control strategy implementation, and investigations. The ideal candidate brings deep expertise in biologics analytics, strong cross‑functional leadership, and experience working with external contract manufacturing companies.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager