The Role
Lead and support sterile drug product manufacturing activities including aseptic filling, process characterization, validation (PPQ), technology transfer, and commercial process support. Author and execute validation protocols, investigations, and change controls. Analyze manufacturing data using statistical tools, drive process optimization, and work cross-functionally with Manufacturing, Quality, Engineering, and Regulatory while managing multiple projects and documentation.
Summary Generated by Built In
• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.
Requirements
• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or
• Master's degree with 3+ years of relevant scientific experience; or
• Bachelor's degree with 5+ years of relevant scientific experience.
A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.
In addition to the minimum educational requirements listed below, candidates should have experience with technical data analysis and scientific documentation. Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required. Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
Skills Required
- Experience supporting sterile drug product manufacturing in pharma or biotech
- Hands-on experience with aseptic filling operations and filling equipment
- Process characterization, process validation (PPQ), and technology transfer experience
- Authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls
- Strong knowledge of GMP requirements, aseptic processing principles, and contamination control strategy
- Experience performing statistical analysis using JMP or Minitab
- Ability to analyze manufacturing data, identify process trends, and recommend data-driven solutions
- Experience working cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services
- Strong technical writing, communication, presentation, and project management skills
- Ability to independently manage multiple projects in a fast-paced manufacturing environment
- Experience with single-use technologies and sterile manufacturing operations
- Doctorate (PhD, PharmD, or MD) OR Master's degree with 3+ years relevant experience OR Bachelor's degree with 5+ years relevant experience
- Degree preferred in Mechanical, Chemical, Biomedical, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related discipline
- Proficiency with Microsoft Office (Excel, Word, PowerPoint)
- Experience with Sample Management Systems such as LIMS and HLEE
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
