This is a high-impact technical role providing Process Development (PD) expertise for large and small molecule drug product manufacturing. You will be instrumental in the characterization and qualification of syringe filling and Single-Use Technologies (SUT) for major site expansion projects and new plant introductions.
Key Responsibilities
- Process Design & SUT: Lead the development, qualification, and implementation of Single-Use Systems for formulation and filling.
- Filling Characterization: Develop filling recipes, author protocols, and execute/report on characterization runs.
- Technical Support: Provide expert troubleshooting for manufacturing issues, investigations, and root cause analysis (NC/CAPA).
- Project Leadership: Lead cross-functional teams and risk assessments to ensure robust technology transfers and process validations.
- Compliance: Ensure all processes align with global regulatory standards (FDA, EU) and verify quality system documentation.
Candidate Profile
Minimum Requirements
- Education: Bachelor's in Science or Engineering with 5+ years of relevant experience (or Master's with 3+ years).
- Technical Knowledge: Deep understanding of Aseptic Manufacturing, cGMP, and fundamental engineering principles applied to filling/formulation.
- Soft Skills: Exceptional technical writing and communication skills; proven ability to lead complex projects to completion.
Preferred Qualifications
- 10+ years of experience in Commercial Protein Drug Product processing.
- Expertise in Tech Transfer, Process Validation, and protein biochemistry (physical/chemical stability).
- Specific experience with Peristaltic Pumping or Time-Pressure Filling technologies.
- Advanced data-driven analysis and visualization skills.
