What are the responsibilities and job description for the Principal Scientist position at VINTABIO, INC.?
About VintaBio, Inc.
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
- Qualify and/or Validate Analytical Test Methods.
- Support QC Scientists in performing routine testing under cGMP Guidelines.
- Support QC Scientists in Data Trending using appropriate statistical analysis.
- Technical participation in Deviations, OOS/OOT’s, CAPA’s and other continuous improvement activities.
- Draft/Revise SOPs, Reports and other documents using sound technical writing skills.
- Participate in Lab/Equipment cleaning and maintenance.
- Comply with cGMPs when applicable, SOPs, safety requirements, and all company policies.
- Other related duties as assigned.
Knowledge, Skills and Abilities
- Must be proficient in performing analytical statistical analysis using appropriate software.
- Strong analytical, problem-solving and critical thinking skills
- Exceptional attention to detail with strong communication and interpersonal skills.
- Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Thrive in a fast-paced, innovative environment, remaining flexible, proactive, resourceful, and efficient.
- Proficient understanding of all the following analytical methods with an emphasis on ELISA and PCR.
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
- BS/BA in Analytical Chemistry, Biology, or related discipline and 10 years of experience in the analytical/pharmaceutical development field. OR
- MS/MA in Analytical Chemistry or related discipline and 8 years of experience OR
- PhD in Analytical Chemistry or related discipline and 5 years of relevant experience; may include postdoc experience
- Experience in method transfer in Analytical Chemistry
Physical Demands
- Ability to lift and carry up to 15lbs
- Ability to push or pull up to 25lbs
- Ability to sit, stand, and walk for extended periods
- Ability to bend, squat, kneel, and reach.
Other Physical Requirements
Must wear appropriate Personal Protective Equipment (PPE) when in the lab.
Work Environment
Work is performed on site in an office and lab setting in Philadelphia, PA.
