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 projectsof 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. SUMMARYThis position will be responsible for activities involving compliance with applicable regulatory requirements within the Manufacturing Group.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Performs the compliance review and approval of all batch documentation related to disposition of clinical products.
- Author deviations and investigations.
- Writing/Reviewing Standard Operating Procedures for manufacturing department.
- Review Master Production Records.
- Performing routine internal audits of Manufacturing processes.
- Write and review protocols for development reports, IQ/OQ's and validations.
- Follows Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs).
- Other duties as assigned or determined by Area Management.
EDUCATION and/or EXPERIENCEBachelor's degree (B. A.) from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.BENEFITSAt 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 INCLUSIONAt 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