Sterile Injectable Product Lead

Viking Therapeutics; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Manager, Injectable Products to lead sterile injectable product development, validation, and lifecycle management.

You will partner with Development, Manufacturing, Quality, Regulatory Affairs, and external CMOs/CDMOs to ensure compliant, robust manufacturing processes across product lifecycles. The role requires 8+ years in pharma/biotech manufacturing with hands-on leadership in aseptic processes, PPQ, and regulatory readiness.

Qualifications

• BS or MS in chemical engineering, pharmaceutical sciences, or related field.
• 8+ years of pharma/biotech manufacturing and technical operations.
• Direct experience supporting sterile injectable products from late-stage to launch.
• Experience supporting PPQ, technology transfer, process validation, and commercial manufacturing operations.
• Strong understanding of aseptic processing and regulatory requirements.
• Excellent project management and cross-functional leadership.

Responsibilities

• Provide technical SME leadership for sterile injectable products from Phase 3 through commercial operations.
• Oversee drug product manufacturing processes: formulation, filling, lyophilization, inspection, packaging, distribution.
• Support validation, control strategies, lifecycle management, and process characterization.
• Ensure compliance with FDA/EMA/ICH GMP requirements and regulatory submissions.
• Lead investigations, CAPAs, change controls, and risk assessments for quality events.
• Support technology transfer, CPV, PPQ, and annual product reviews with partners.

Skills

Tech Operations Leadership

Process Validation/PPQ

Aseptic Manufacturing

Commercialization/Lifecycle

Regulatory/Inspection Readiness

Quality Risk Management

Cross-Functional Leadership

External Partner Management

Strategic Problem Solving

Continuous Improvement

Education

BS/MS in Chemical Engineering or related field

Job description

Viking Therapeutics, Inc. is seeking a Manager, Injectable Products to lead sterile injectable product development, validation, and lifecycle management.

You will partner with Development, Manufacturing, Quality, Regulatory Affairs, and external CMOs/CDMOs to ensure compliant, robust manufacturing processes across product lifecycles. The role requires 8+ years in pharma/biotech manufacturing with hands-on leadership in aseptic processes, PPQ, and regulatory readiness.