Principal Scientist

We are seeking an experienced Principal Scientist to support technology transfer activities and provide scientific, technical, and compliance expertise to sterile manufacturing operations. This role will support the Site Subject Matter Expert (SME) and Process Owner for liquid and lyophilized parenteral manufacturing processes, ensuring operations remain in a validated state and compliant with cGMP regulations, site procedures, and regulatory requirements.

The incumbent must comply with all Environmental Health & Safety (EHS), security, and Good Manufacturing Practice (GMP) requirements.

Key Responsibilities

• Support the site SME for liquid and lyophilized parenteral processes, including formulation, filling, lyophilization, and capping operations.
  
• Lead and support technology transfer projects, including project planning, execution, and cross-functional coordination.
  
• Develop, execute, and review process characterization, validation, and technical transfer protocols.
  
• Support activities such as Mixing Studies, Filling Studies, Lyophilization Studies, Capping Studies, and PQ Washer & Tunnel studies.
  
• Prepare, review, and verify technical documentation, including:
  • Technical Transfer Documents
    
  • Validation Plans and Reports
    
  • Mixing Studies
    
  • Excipient and Drug Product Holding Time Studies
    
  • Filling and Capping Machinability Studies
    
  • Lyophilization Studies
    
• Analyze manufacturing data, investigate process issues, and implement continuous improvement initiatives.
  
• Collaborate with Manufacturing, Quality, Engineering, Validation, and Global Technical Operations teams.
  
• Support regulatory inspections, audits, deviations, change controls, and CAPA activities as needed.
  
• Participate in project meetings and provide technical recommendations to stakeholders.
  

Requirements

• Ph.D., Master's, or Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Microbiology, or a related scientific field.
  
• 4-6 years of experience in the pharmaceutical or biotechnology industry, preferably in sterile manufacturing operations.
  
• Strong experience with technology transfers, aseptic processing, process validation, and cGMP requirements.
  
• Knowledge of FDA, EMA, ICH, and global regulatory guidelines.
  
• Experience with root cause investigations, risk assessments, and process troubleshooting.
  
• Excellent technical writing, project management, and communication skills.
  
• Bilingual (English and Spanish).