Senior Manager, Biologics Analytical Development (Bioassay)

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 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 bioassay 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 Education PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline Experience 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) Ligand‑binding assays (ELISA, MSD, ECL platforms) 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. 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. Disclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Equal Opportunity Employer 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. Disability Accommodation 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 Accommodation Request (View email address on click.appcast.io). #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.