Bioassay Program Lead, Biologics Analytics

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

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.