Senior Manager, Biologics Analytical Development (Bioassay)

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 110,000 - 145,000; Full time

Job summary

Otsuka Pharmaceutical Companies (U.S.) is looking for a Sr. Manager, Biologics Analytical Development (Bioassay). In this role, you will execute and support the development, qualification, and lifecycle management of bioassays necessary for biologics programs. You will lead scientific oversight for assays critical to product characterization and regulatory submissions.

Your experience should include 8-10 years in analytical development with a focus on bioassays. A PhD in a related field is required. Strong leadership skills and regulatory knowledge are essential for this position.

Qualifications

• 8–10+ years of experience in analytical development for biologics, with a strong emphasis on bioassay development.
• Demonstrated leadership experience managing scientific teams.
• Strong hands-on and theoretical knowledge of cell-based and ligand-binding assays.

Responsibilities

• Execute and support the development of bioassays for biologics programs.
• Serve as subject matter expert for bioassay activities.
• Oversee method transfer to internal QC or contract testing laboratories.

Skills

Bioassay development

Analytical development for biologics

Leadership experience

Cell-based assays

Ligand-binding assays

Regulatory submissions

Education

PhD in Biology, Biochemistry, Immunology, Bioengineering

Job description

The Sr. Manager, Biologics Analytical Development (Bioassay) will execute and support the development, qualification, and lifecycle management of bioassays supporting biologics programs from early development through late-stage clinical and commercial manufacturing. This role provides scientific technical oversight for cell-based and ligand-binding assays to support product characterization, potency determination, comparability, and regulatory submissions.

Key Responsibilities

• Execute and support development, optimization, qualification, and validation of bioassays, including cell-based potency assays and 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.

Qualifications & Experience

• 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) and ligand‑binding assays (ELISA, MSD, ECL platforms), and potency assay design, qualification, and validation.
• Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays.

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.