Quality Control Scientist

ABOUT VGXI Inc.

VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers. 

If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI. 

SUMMARY

The Quality Control Scientist is responsible for new assay development, method transfers, risk assessments, assay qualifications, change controls and validations. Assays must be assessed, developed, validated, and implemented in a timely manner.  It is also the responsibility of this position to troubleshoot any problems that may arise and to be up to date on all methods applicable for our use.  Quality Control Scientist will also participate in testing of products manufactured and will participate in testing to support manufacture at VGXI. Set-up, organization, and day-to-day operations of a Quality Control Lab are also required.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Responsible for one or more QC assays as follows:                                                                       

• Endotoxin                                                               
• Host Cell Protein Quantitation
• DNA Concentration by A₂₆₀ and Purity by _A260/280
• Plasmid Forms Analysis
• Gel electrophoresis                                   
• pH / conductivity                                                  
• RNA Quantitation                                                            
• Osmolality                                                                  
• Transcriptional Activity/Cell culture
• Restriction
• Host Cell Genomic DNA Quantitation
• ELISA assays
• CGE

Responsible for documentation/administration as follows:

• Organize all accumulated data.
• Keep notebooks up to date, signed, and reviewed.
• Write development reports and perform risk assessments.
• Write validation protocols and reports.
• Data reduction using software programs.
• Write Standard Operating Procedures and Protocols.

Responsible for QC analysis as follows:                                             

• Spectromax software                                
• HPLC software                                 
• Gel imaging software                        
• PowerPoint, Excel, and Word software                       

Other General Duties:

·        Lab supplies (stocked, ordered, and labeled)

·        Clean lab (trash removal, sweeping, etc.)

·        Calibration and preventive maintenance of equipment

EDUCATION and/or EXPERIENCE

Bachelor’s Degree (B.S.) or equivalent; or five to seven years related experience and/or training; or equivalent combination of education and experience.

BENEFITS

At VGXI, we recognize that our employees are at the heart of our success, and we offer exceptional benefits that reflect our commitment to their well-being. Our comprehensive offerings include a range of quality benefits, available to our employees from day one (no waiting period). Benefits include:

• Medical
• Dental
• Vision
• Life Insurance
• Short-Term and Long-Term Disability
• 401K Plan
• Flexible Spending Account
• Tuition Reimbursement
• Paid Time Off Including Holidays, Vacation and Sick/Personal Leave.

DIVERSITY, EQUITY AND INCLUSION

At VGXI, we are committed to recognizing and valuing you. Our diverse backgrounds, perspectives, and contributions fuel innovation and allow us to success both as individuals and as a team. We have established and embrace a culture of acceptance and inclusion with equity in recruiting, hiring, developing, and investing in talented people. Our commitment to these principles supports a diverse workforce and empowers us to achieve our mission of leading the industry in producing the next generation of therapeutics to improve patients’ lives.

Equal Opportunity Employer