Senior Biologics Downstream Development Lead

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) match

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager, Biologics Downstream Development to lead hands-on purification process development for biologics programs across development stages. You will guide chromatography, filtration, viral clearance, and UF/DF, interfacing with CDMOs and internal teams to ensure robust CQAs and CPPs.

The role requires strong scientific judgment, cross-functional collaboration, and the ability to independently drive complex CMC deliverables, including

Qualifications

• Experience in biologics downstream processing including purification and protein sciences.
• 5+ years in industry with leadership of technical staff.
• Strong knowledge of cGMP, ICH Q8/Q9/Q10 and data integrity.
• Experience with tech transfer and vendor management.
• Familiarity with DoE methods and data analysis (e.g., JMP).

Responsibilities

• Execute and support downstream process development activities for assigned biologics programs under functional leadership.
• Design, develop, optimize, and characterize purification processes including chromatography, filtration, viral clearance, and UF/DF.
• Generate data and support for process understanding, CPPs and CQAs, and support development of control strategies.
• Apply scientific approach to support development and optimization of purification process.
• Support technical interactions with CDMOs, ensuring alignment with defined development plans.
• Support definition of downstream work plan and deliverables.
• Review and approve CDMO-authored documents including development plans, protocols, reports, batch records, deviations, and investigations.
• Support technical issue resolution with CDMOs, including troubleshooting, root-cause analysis, and implementation of corrective actions.
• Support downstream process transfers into and out of CDMOs, including authoring and reviewing transfer documentation.
• Author and contribute to downstream-related sections of regulatory filings (IND, IMPD, BLA, MAA).
• Provide technical input to support downstream process for regulatory interactions, responses to agency questions, and inspections.
• Ensure all downstream activities comply with applicable GMP, regulatory, and internal quality requirements.

Skills

Downstream processing

Leadership

cGMP knowledge

Design of Experiments

Data integrity

Education

Bachelor's degree in Chemical Engineering/Biochemistry/Biotechnology

Master's degree (5+ years exp)

PhD (5+ years exp)

Tools

JMP

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager, Biologics Downstream Development to lead hands-on purification process development for biologics programs across development stages. You will guide chromatography, filtration, viral clearance, and UF/DF, interfacing with CDMOs and internal teams to ensure robust CQAs and CPPs.

The role requires strong scientific judgment, cross-functional collaboration, and the ability to independently drive complex CMC deliverables, including