Biologics MSAT Analytics Director – Tech Transfer

Biopharma Careers

United States

Remote

USD 169,000 - 253,000

Full time

14 days+

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Benefits offered by this job

Medical, dental, vision

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka is seeking an Associate Director of MSAT – Analytical Sciences to lead the analytical lifecycle for biologics and support tech transfer and commercial manufacturing. You will oversee method validation, QA coordination, and external partner oversight while ensuring data integrity across MSAT activities.

The role requires senior expertise in biologics analytics, cross-functional leadership, and regulatory experience for BLA/MAA submissions.

Qualifications

Requires PhD or MS in a relevant field with 8+ years (PhD) or 12+ years (MS) in analytical development, QC, or MSAT for biologics.
Deep expertise in analytical methods for biologics (e.g., HPLC/UPLC, CE, LC-MS, bioassays).
Experience supporting commercial biologics manufacturing, tech transfer, and method lifecycle management.
Strong knowledge of regulatory expectations for biologics (ICH/Q5, Q6, Q8, Q14; FDA/EMA guidance).

Responsibilities

Lead the analytical sciences function within MSAT to support commercial biologics manufacturing.
Drive analytical control strategy, specification setting, and lifecycle management.
Oversee method performance monitoring, trending, and capability assessments.
Provide SME support during technology transfers to external sites.
Lead root-cause analyses for investigations and CAPA.
Guide method troubleshooting and CQAs–CPP process links.
Lead qualification/validation strategies for Phase-appropriate and commercial needs.
Prepare analytical sections of regulatory filings (BLA/MAA).