Manager, Injectable Products

The Manager, Injectable Products serves as a technical leader and Subject Matter Expert (SME) for sterile injectable drug products across late-stage development, Process Performance Qualification (PPQ), commercial launch, regulatory approval, and lifecycle management activities.

This role provides strategic and hands‑on technical leadership for biologic and small molecule injectable products, including liquid, lyophilized, and combination presentations. The individual will support technology transfer, process validation, commercial manufacturing, regulatory submissions, inspection readiness, and continuous process improvement initiatives.

The position partners closely with Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Analytical Development, and external manufacturing partners (CMOs/CDMOs) to ensure robust, compliant, and reliable manufacturing processes throughout the product lifecycle.

• Serve as the technical SME for sterile injectable products from Phase 3 clinical development through commercial operations.
• Provide technical leadership for drug product manufacturing processes, including formulation, filling, lyophilization, inspection, packaging, and distribution.
• Support process characterization, control strategy development, validation, and lifecycle management activities.
• Ensure compliance with FDA, EMA, ICH, and global regulatory requirements for sterile injectable products.
• Support preparation and defense of CMC content for regulatory submissions, inspections, and agency interactions.

• Provide technical oversight for commercial manufacturing operations involving sterile injectable products.
• Support technology transfer activities between development organizations, CMOs, CDMOs, and commercial manufacturing sites.
• Lead technical investigations associated with manufacturing deviations, process excursions, product quality events, and yield improvements.
• Support PPQ execution, Continued Process Verification (CPV), Annual Product Reviews, and ongoing process monitoring initiatives.
• Identify and implement process improvements that enhance product quality, manufacturing robustness, compliance, and supply reliability.
• Serve as a technical representative during Health Authority inspections and Pre-Approval Inspections (PAI).

• Lead process validation strategies and execution for commercial injectable products.
• Review and approve validation protocols, reports, risk assessments, and change controls.
• Support equipment qualification, cleaning validation, aseptic process simulations, and container closure validation activities.
• Drive lifecycle management activities, including post-approval changes, process optimization, and manufacturing scale‑up initiatives.
• Ensure product and process knowledge is effectively transferred and maintained across manufacturing sites.

• Provide technical support for aseptic processing, sterile filtration, filling operations, lyophilization, and visual inspection processes.
• Evaluate manufacturing performance trends and recommend improvements to process capability and operational efficiency.
• Support contamination control strategies and aseptic manufacturing best practices.
• Collaborate with site operations to resolve technical challenges and support uninterrupted product supply.

• Lead complex investigations related to product quality, manufacturing deviations, out‑of‑specification results, and process performance issues.
• Facilitate root cause analysis and development of effective CAPAs.
• Ensure compliance with GMP requirements and…