Analytical Scientist III

About the role

Participate in the development, qualification, phase-appropriate validation, and execution of various analytical methods used to test, characterize, and release GMP Raw Materials, In-Process Samples, Drug Substance, and Drug Products.

Responsibilities

• Develop analytical test methods in accordance with regulatory requirements and author respective development reports.
• Lead or assist in troubleshooting methods or equipment.
• Train other scientists in analytical test methods.
• Author protocols, execute protocols, analyze data, and prepare final reports for qualification and phase-appropriate validation of analytical test methods.
• Perform routine testing using analytical test methods under cGMP guidelines.
• Conduct GMP review of data, reports, CAPAs, change controls, and other documents to confirm compliance with specifications and regulatory requirements.
• Participate in deviations, CAPAs, and continuous improvement activities.
• Lead laboratory investigations for deviations, invalid assays, 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 programs.
• Assist with lab and 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.
• Foster a culture of accountability, transparency, collaboration, and continuous improvement within the team.
• Serve as a 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, and associated metrics.
• Promote safe operating and working procedures.

Requirements

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

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 of the following platforms: immunoassay, qPCR/dPCR, or cell-based assays.
• Experience in Dynamic Light Scattering, Electrophoresis, and Flow Cytometry is a plus.
• In-depth knowledge of cGMP, FDA, ICH, and USP guidelines and practices in a GMP pharmaceutical QC laboratory.
• Proficiency in Microsoft Office products and ability to 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.
• Ability to thrive in a fast-paced, innovative environment, remaining flexible, proactive, resourceful, and efficient.

Physical Requirements

• Must wear appropriate Personal Protective Equipment (PPE), including lab coat, gloves, and safety glasses.
• Work is performed on-site primarily in office and lab settings.
• Weekend work as needed.