Manager, Injectable Products

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.

Essential Duties and Responsibilities

Injectable Product Technical Leadership

• 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.

Manufacturing & Technical Operations Support

• 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).

Process Validation & Lifecycle Management

• 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.

Sterile Manufacturing Expertise

• 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.

Investigations, Quality & Compliance

• 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 internal quality systems.
• Participate in audits, inspection readiness activities, and regulatory responses.
• Apply Quality Risk Management principles to support decision-making and process improvements.

CMC & Regulatory Support

• Provide technical support for regulatory submissions, supplements, annual reports, and responses to health authority questions.
• Collaborate with Regulatory Affairs and Development teams to support product approvals and post-approval changes.
• Ensure alignment between manufacturing processes, control strategies, and regulatory commitments.
• Support inspection preparation and regulatory agency interactions.

Supplier & External Partner Management

• Provide technical oversight of CMOs, CDMOs, and critical raw material suppliers.
• Support supplier qualification, technical assessments, investigations, and change management activities.
• Collaborate with external partners to resolve manufacturing and quality challenges.
• Evaluate manufacturing capabilities and readiness to support commercial product demand.

Cross-Functional Collaboration

• Partner with Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Engineering functions.
• Support commercialization activities and launch readiness…