Senior Manager, Biologics Analytical Development (CMC Attribute Science)

The Senior Manager, CMC Data Analytics is responsible for  Executing and supporting  data-driven integration, analysis, and interpretation of CMC data to support biologics development from IND-enabling studies through BLA submission and commercialization.

This role serves as a CMC analytics subject matter expert (SME) who partners across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to analyze, summarize and process datasets into clear regulatory narratives, risk-based control strategies, and informed CMC decisions. The position plays a critical role in ensuring data quality, consistency, traceability, and regulatory readiness for global filings.

Key Responsibilities:

•  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.

Qualifications

Education

• M.S in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related discipline

Experience:

• 8 – 10 years of Demonstrated experience supporting IND and BLA submissions, with direct involvement in data presentation and regulatory narratives.
• Proven track record applying CMC data analytics to support comparability, control strategies, and regulatory filings.

Technical Expertise

• Strong understanding of analytical methods and data types used in biologics CMC (e.g., purity, potency, identity, stability).
• 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.

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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