Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, Biologics Analytical Development (Bioassay) to lead the development and lifecycle management of bioassays for biologics programs. The role involves providing scientific oversight, managing assay strategies, and ensuring compliance with regulatory standards.

Responsibilities

• Execute and support development, optimization, qualification, and validation of bioassays, including:
• Cell-based potency assays
• Binding and functional bioassays (e.g., ELISA, MSD, SPR, flow cytometry)
• Support development of assay strategies aligned with regulatory expectations for biologics
• Manage assay robustness, transfer, and comparability across product lifecycle stages
• Serve as subject matter expert (SME) resource supporting bioassays activities on cross-functional project teams
• Provide technical input to CMC, Regulatory, Quality, and Process Development functions
• Contribute to assay strategies for IND, BLA/MAA, and post-approval changes
• Ensure high quality and timely delivery of analytical , compliance, and continuous improvement
• Author, review, and approve technical documents including development reports, protocols, validation reports, and regulatory filings
• Provide analytical support and technical input for regulatory submissions and inspections
• Ensure activities are conducted in compliance with GLP/GMP and data integrity standards
• Oversee method transfer to internal QC or external contract testing laboratories (CDMOs/CROs)
• Coordinate and oversee outsourced bioassay activities and ensure alignment with project timelines and quality expectations
• Evaluate assay technologies and recommend improvements to enhance assay performance and efficiency

Skills

• PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline
• 8–10+ years of experience in analytical development for biologics, with strong emphasis on bioassay development
• Demonstrated leadership experience managing scientific teams
• Experience supporting biologics development activities and contributing to regulatory submissions
• Strong hands-on and theoretical knowledge of cell-based assays (reporter gene, proliferation, cytotoxicity, signaling assays)
• Strong hands-on and theoretical knowledge of ligand-binding assays (ELISA, MSD, ECL platforms)
• Strong hands-on and theoretical knowledge of potency assay design, qualification, and validation
• Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays

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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