Process Engineering Senior Scientific Associate
2 months ago
Job Description
General Summary:
Vertex is seeking a talented Process Engineering Senior Scientific Associate to join our Process Development team. This individual will support late phase cell therapy process development, including performing process optimization activities, and characterization of a cell-based product for ongoing and future projects. This role may contribute to the exploration and establishment of novel cell culture technologies.
Key Duties and Responsibilities:
- Design and perform pluripotent stem cell culture and differentiation experiments to support process optimization and characterization
- Support the application of DOE/QBD principles to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings
- Coordinate studies within department and cross-functionally to evaluate process improvements and ensure GMP compliance and process robustness
- Draft study protocol and reports, ensures data integrity
- Prepare, interpret and present data generated from lab studies
- Solve and address routine problems through standard troubleshooting
- Apply fundamental scientific and engineering principles to process design, development, and process understanding
- Support general laboratory and equipment maintenance
Required Qualifications:
- A Master’s degree in Biochemistry, Engineering, Biology or related discipline and 0-2 years of experience, or BS degree and 3+ years of experience
- Process development experience in a bio-pharmaceutical setting
- Expanded conceptual knowledge and understanding of the principles of molecular and cell biology
- Experience in aseptic processing and cell culture
- Ability to effectively communicate findings, progress, and problems
- Ability to collaborate and work effectively in a multidisciplinary team
- Strong organizational skills and high attention to details
- Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel, imaging software, and specialized applications in use in the laboratory
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