Associate Director, MSAT - Analytical Sciences (Biologics)

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.

Key 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.

Qualifications

Required

• 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.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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