Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager for Biologics Analytical Development. This role is responsible for executing and supporting data-driven integration and interpretation of CMC data to facilitate biologics development and ensure regulatory readiness.
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 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
- M.S in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related discipline
- 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
- 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
- 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
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
- Paid leave programs
- Other company provided benefits
Company Overview
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