Senior Manager, Biologics Analytical Development – CMC Attribute Science

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Execute and support integration, analysis, visualization, and interpretation of CMC data across early, late, and commercial development stages • Aggregate and trend analytical, process, stability, and comparability datasets for 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 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 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 for scientific accuracy and regulatory fitness • Support data transfers and reconciliation during technology transfers and manufacturing transitions • Serve as a CMC analytics subject matter expert and partner across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs • Support data quality, consistency, traceability, and regulatory readiness for global filings

🎯 Requirements

• M.S. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related discipline • 5–10 years of demonstrated experience supporting IND and BLA submissions • 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, including purity, potency, identity, and 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

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity