QC Analytical Scientist III

Description

Position Summary

The Quality Control Analytical Scientist III will participate in the development, qualification, phase-appropriate validation, and execution of various analytical methods that are used to test, characterize and release GMP Raw Materials, In-Process Samples, Drug Substance, and Drug Products.   

Essential Functions

• Participate in the development of Analytical Test Methods in accordance with regulatory requirements and author respective development reports. 
• Lead or assist other scientists in troubleshooting methods or equipment. 
• Train other scientists in Analytical Test Methods. 
• Participate in the authoring of protocols, execution of protocols, data analysis, and respective final report for the Qualification and Phase-appropriate validation of Analytical Test Methods.
• Perform routine testing utilizing Analytical Test Methods under cGMP Guidelines.
• Perform GMP review of data, reports, CAPAs, change controls, and other documents      to confirm data meets all specifications and regulatory requirements.
• Participate in Deviations, CAPA’s, and other continuous improvement activities. 
• Lead and provide guidance on laboratory investigations for deviations, invalid assays and OOS test results, and other QC laboratory non-conformance using established procedures. 
• Author and propose revisions to SOPs, Protocols, Reports, and other documents using sound technical writing skills. 
• Participate in 5S and Lean Labs program. 
• Participate in Lab/Equipment cleaning and maintenance. 
• Comply with cGxPs, SOPs, safety requirements, and all VintaBio policies. 
• Drive continuous improvement and introduce new testing platforms for Analytical Testing programs at VintaBio. 
• Continue to foster the VintaBio culture of accountability, transparency, collaboration, and continuous improvement within the team through self-awareness and example. 

Other Functions

• Serve as Subject Matter Expert in current and future Analytical Test Methods. 
• Participate in audits and inspections, internal and external. 
• Produce periodic reports for tracking, evaluation of trends, associated metrics, etc. 
• Promote safe operating and working procedures. 
• Other duties as assigned. 

Knowledge, Skills, and Abilities

• Experience in analytical assay development including DOE and/or qualification and phase-appropriate validation of analytical methods.
• In-depth hands-on experience in two (2) of the three (3) following platforms: 

1. immunoassay, 
2. qPCR/dPCR,  
3. or cell-based assays. 
4. Experience in Dynamic Light Scattering, Electrophoresis, and Flow Cytometry a plus. 

• In depth knowledge of cGMP, FDA, ICH, and USP guidelines and practices in a GMP pharmaceutic QC laboratory. 
• Must be proficient in Microsoft Office products and perform analytical statistical analysis using appropriate software. 
• Excellent oral and written communication with strong technical writing experience and strong interpersonal skills.
• Exceptional attention to detail.  
• Ability to work independently or with 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. 

Position Requirements

Education and Experience: 

• Bachelor’s degree or higher in Biological Sciences. 
• 10+ years of GMP pharmaceutical industry experience, time requirement may be waived pending degree level.

Physical Requirements: Must wear appropriate Personal Protective Equipment (PPE) which includes, but not limited to, Lab Coat, Gloves, Safety Glasses.

• Work is performed on site primarily in office and lab setting. 
• Weekend work as needed.

Why Join VintaBio?

At VintaBio, you'll have the opportunity to work alongside talented scientists and manufacturing professionals who are advancing next-generation gene therapy manufacturing. You'll play a key role in bringing innovative therapies closer to patients while helping build scalable GMP operations in a collaborative, science-driven environment.