QC Analytical Scientist III

The O'Connor Group TOG Inc. • Philadelphia, PA

just now • Onsite

About The Position

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.

Requirements

• 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: immunoassay, qPCR/dPCR, or cell-based assays.
• 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.
• Bachelor’s degree or higher in Biological Sciences.
• 10+ years of GMP pharmaceutical industry experience, time requirement may be waived pending degree level.

Nice To Haves

• Experience in Dynamic Light Scattering, Electrophoresis, and Flow Cytometry a plus.

Responsibilities

• 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.
• 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.

Benefits

• Opportunity to work alongside talented scientists and manufacturing professionals.
• Play a key role in bringing innovative therapies closer to patients.
• Help build scalable GMP operations.
• Collaborative, science-driven environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior