Senior Manager, Biologics Downstream Development

Role Description

The Senior Manager, Biologics Downstream Development is an experienced technical individual contributor responsible for the execution of downstream process development activities for biologics programs across the development lifecycle. This role serves as a downstream subject matter expert (SME), providing hands-on technical leadership for purification process design, optimization, scale-up, and external execution at CDMOs.

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

Key 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.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemistry, or Biotechnology with 10+ years of experience; OR Master’s with 7+ years; OR PhD with 5+ years of relevant industry experience.
• Significant expertise in biologics downstream processing (purification, protein sciences).
• At least 2-5 years of experience in supervising technical staff.
• Strong knowledge of cGMP, ICH Q8/Q9/Q10, and data integrity standards.
• Experience in DoE (Design of Experiments) tools (e.g., JMP), tech transfer, and vendor management.

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.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.

Application Deadline

This will be posted for a minimum of 5 business days.