Senior Manager, Biologics Analytical Development (CMC Attribute Science)

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

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

Job summary

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.

Qualifications

• 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

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.

Skills

Analytical data analysis

Statistical analysis

Data visualization

Education

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

Job description

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:

• 5 – 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.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

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.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].