Manager, Injectable Products

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.

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 initiatives.
  • Drive alignment between internal stakeholders and external manufacturing organizations.
  • Contribute technical expertise to strategic product and portfolio decisions.
• Project Leadership
  • Lead technical workstreams supporting product commercialization, process validation, technology transfer, and lifecycle management.
  • Mentor junior engineers and scientists within the organization.
  • Manage multiple projects and priorities while ensuring timelines, quality standards, and business objectives are achieved.
  • Support strategic initiatives within the Injectables & Devices organization.
• Other duties as assigned.

Requirements

• BS or MS in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemistry, Biology, or related scientific discipline.
• 8+ years of experience in pharmaceutical or biotechnology manufacturing and technical operations.
• Direct experience supporting sterile injectable products from late-stage development through commercial launch.
• Experience supporting PPQ, technology transfer, process validation, and commercial manufacturing operations.
• Strong understanding of aseptic processing, sterile manufacturing, and injectable drug product lifecycle management.
• Experience leading technical investigations, CAPAs, change controls, and risk assessments.
• Knowledge of FDA, EMA, ICH, GMP, and global regulatory requirements.
• Demonstrated experience supporting regulatory inspections and audit readiness activities.
• Strong project management, technical writing, and cross-functional leadership skills.
• Excellent communication and stakeholder management capabilities.

Skills

• Sterile Injectable Product Expertise
• Technical Operations Leadership
• Process Validation & PPQ Execution
• Aseptic Manufacturing Knowledge
• Commercialization & Lifecycle Management
• Regulatory Compliance & Inspection Readiness
• Quality Risk Management
• Cross-Functional Leadership
• External Partner Management
• Strategic Problem Solving
• Continuous Improvement & Operational Excellence

Preferred Qualifications

• Advanced degree (MS, PharmD, or PhD) in Engineering, Pharmaceutical Sciences, or related scientific field.
• Experience with biologics, monoclonal antibodies, peptides, gene therapies, or other sterile injectable products.
• Experience with lyophilized drug products and aseptic filling operations.
• Experience supporting global regulatory submissions and product approvals.
• Experience managing CMOs/CDMOs and global manufacturing networks.
• PMP, Lean Six Sigma, or related certification.

Pay

$140,000.00 - $155,000.00 annual salary