Position SummaryThe 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:
- immunoassay,
- qPCR/dPCR,
- or cell-based assays.
- 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 RequirementsEducation 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.
