Senior Manager, CMC Data Analytics – Biologics

Otsuka Pharmaceutical Co., Ltd.; United States; A distancia; USD 150.000 - 224.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Descripción de la vacante

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Manager, CMC Data Analytics to execute and support data-driven integration, analysis, and interpretation of CMC data for biologics development from IND-enabling studies to BLA submission and commercialization.

The role partners across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to drive regulatory-ready narratives and risk-based control strategies, ensuring data quality and traceability for global filings.

Formación

• Strong understanding of analytical methods and data types used in biologics CMC
• Experience with statistical analysis, data trending, and visualization in a regulated environment
• Solid knowledge of regulatory expectations for CMC data integrity, traceability, and lifecycle management

Responsabilidades

• Execute and support integration, analysis, visualization, and interpretation of CMC data across development stages (early, late, and commercial).
• Aggregate and trend analytical, process, stability, and comparability datasets to support CMC decision-making and regulatory strategy.
• Apply statistical and scientific approaches to evaluate variability, trends, and comparability across manufacturing changes and lifecycle events.
• Translate complex CMC datasets into clear, defensible conclusions for internal governance and regulatory submissions.
• Partner with Analytical Development to interpret method performance, lifecycle data, and validation outcomes in a CMC context.
• Collaborate with Upstream, Downstream, and MSAT teams to link process performance with product quality attributes.
• Provide analytical data and insights to support control strategy development.
• Perform data analysis to support comparability assessments under guidance for process changes, scale-up, site changes, and technology transfers.
• Review and support evaluation t of CMC data generated by CDMOs and external testing laboratories.
• Review external reports, datasets, and summaries to ensure scientific accuracy and regulatory fitness.
• Support data transfers and reconciliation activities during tech transfers and manufacturing transitions.

Conocimientos

Analytical data analysis

Statistical analysis

Data visualization

Educación

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

Descripción del empleo

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Manager, CMC Data Analytics to execute and support data-driven integration, analysis, and interpretation of CMC data for biologics development from IND-enabling studies to BLA submission and commercialization.

The role partners across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to drive regulatory-ready narratives and risk-based control strategies, ensuring data quality and traceability for global filings.