What are the responsibilities and job description for the Principal Analytical Scientist position at VintaBio?
VintaBio is a technology company focused on simplifying viral vector production. Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. Our research core produces high-yield and world-class POC vectors. Through a comprehensive production workflow that utilizes VintaBio's proprietary cell lines and transfection reagents, we expedite the path to the clinic, offer more reliable manufacturing, and improve economics.
Position Summary
The Principal Scientist is responsible for leading the development of analytical methods, GMP qualification of those methods and transfer to Quality Control for routine GMP operations. The analytical methods will be used to test and characterize GMP Raw Materials, In-Process Samples, Drug Substance and Drug Products. The Principal Scientist will also be responsible for technical oversight of external testing laboratories and for bringing innovation into VintaBio as it contributes to the organization’s overall mission of delivering cost effect viral vectors.
Key Responsibilities
Analytical Development
- Design and develop Analytical Test Methods using USP, ICH, and any other related guidances for which the Analytical Test Method will be used.
- Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on manufacturing plans for all projects
- Drive accuracy, range, precision, repeatability, and robustness of methods in an environment of complex, dynamic sample matrices
- Identify opportunities for new method development or process improvements to drive down costs and improve execution / repeatability.
- Train and oversee other Scientists on Analytical Test Methods.
- Assist and mentor other Scientists in troubleshooting of equipment and methods.
- Comply with and enforce data integrity through development and execution.
- Serve as Subject Matter Expert in current and future Analytical Test Methods.
GMP Qualification and Support
Knowledge, Skills and Abilities
o ELISA
o PCR – dPCR, ddPCR , qPCR
o Gel Electrophoresis - Silver Stain and Western Blot
o Spectrophotometry
o Cell Culture (Adherent and Suspension)
o HPLC
o Mass Spectrometry
o Flow Cytometry
o Transfection Assays
o Dynamic Light Scattering
o Osmolarity and Osmolality
o pH
Education and Experience
Physical Demands
Other Physical Requirements
Must wear appropriate Personal Protective Equipment (PPE) when in the lab.
Work Environment
Work is performed on site 5 days a week in an office and lab setting in Philadelphia, PA.
