Senior Biologics CMC Analytics Lead — Data Strategy

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) match

Paid holidays and leave programs

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, CMC Data Analytics to drive data-driven decisions across IND-enabling studies through BLA submission and commercialization.

You will partner with Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to analyze datasets, develop regulatory narratives, and ensure data quality and regulatory readiness for global filings.

Qualifications

• CMC data analytics expertise.
• Strong statistical analysis and data Trending.
• Experience translating data into regulatory narratives.

Responsibilities

• Execute and support data integration, analysis, visualization, and interpretation of CMC data across development stages.
• Aggregate and trend analytical, process, stability, and comparability datasets for CMC decisions and regulatory strategy.
• Apply statistical and scientific methods to evaluate variability and trends across manufacturing changes and lifecycle events.
• Translate complex datasets into clear, defensible conclusions for governance and regulatory submissions.
• Collaborate with Analytical Development to interpret method performance and lifecycle data in a CMC context.
• Link process performance with product quality attributes across Upstream, Downstream, and MSAT teams.
• Provide analytical data and insights to support control strategy development.
• Support comparability assessments for process changes, scale-up, site changes, and technology transfers.

Skills

CMC data analytics

Statistical analysis

Data visualization

Regulatory submissions

Data integrity

Cross-functional collaboration

Education

MS in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, CMC Data Analytics to drive data-driven decisions across IND-enabling studies through BLA submission and commercialization.

You will partner with Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to analyze datasets, develop regulatory narratives, and ensure data quality and regulatory readiness for global filings.