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

This role centers on the development, implementation, and administration of critical Information Technology (IT), Operational Technology (OT), and Automation Systems, with a significant focus on cybersecurity and systems integration. The role is responsible for ensuring the reliability, security, and efficiency of information systems (IT/OT), seamless integration and efficient technology utilization to enhance productivity, compliance, and data integrity. This involves leading implementations by adhering to IT/OT and cybersecurity best practices, cGMP regulations, and relevant industry standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

IT Infrastructure & Administration

• Oversee Microsoft 365, Azure, and Entra AD administration, including user provisioning, group policy management, and SharePoint/Teams administration.
• Ensure robust and efficient implementation and operation of core network services, such as Active Directory, DNS, DHCP, group policies, virtual environments, and backup solutions.
• Collaborate with IT infrastructure resources on the establishment of physical and virtual servers, storage area networks (SANs), routers, switches, firewalls, and wireless access points, ensuring high availability and performance.
• Provide Tier 2/3 technical support for complex IS and automation system issues, ensuring timely and effective resolution for end-users.
• Support robust, systematic backups and recovery processes, including regular testing of disaster recovery plans to ensure data integrity and business continuity.
• Evaluate, optimize, and recommend new technologies and hardware solutions to enhance IT and OT capabilities.
• Collaborate with IT and OT teams for project implementations and system configurations, ensuring proper setup and functionality.

Systems Integration, Operational Technology and Automation

• Plan, execute, and manage enterprise systems integration projects, ensuring seamless data flow and interoperability between systems and business applications.
• Work closely with business and process teams to understand data requirements and design effective integration solutions.
• Develop and maintain integration tools to automate workflows and data exchange.
• Collaborate with cloud-based system providers to ensure effective and robust deployments and integrations.
• Provide technical guidance for the deployment and integration of business, quality, and automation systems, including Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), Enterprise Resource Planning (ERP) systems, Regulatory Asset Management (RAM) Systems, Process Control Systems (PCS), Manufacturing Execution Systems (MES), and their corresponding data management and backup platforms.
• Support the installation and configuration of operational technology systems, ensuring accurate and secure data collection and storage for process development and manufacturing.
• Support strategies for establishing industrial automation best practices, adhering to standards such as ISA/IEC, ISO, GAMP, and IEEE.

Cybersecurity, Compliance and Strategic Planning

• Lead strategic planning and deployment of a robust, sustainable cybersecurity program.
• Implement and enforce strong cybersecurity measures, including firewalls, intrusion detection/prevention systems (IDS/IPS), anti-malware solutions, endpoint detection and response (EDR), and data loss prevention (DLP) strategies.
• Support Identity and Access Management (IAM) solutions, including multi-factor authentication (MFA) and single sign-on (SSO).
• Conduct and support vulnerability assessments and penetration testing to identify and mitigate security weaknesses.
• Monitor systems for security events and incidents, ensuring prompt alerts and escalation.
• Develop, implement, and enforce security policies and procedures, and provide ongoing security awareness training for employees.
• Ensure compliance with relevant industry regulations and data privacy standards, including HIPAA, GLP/GMP, and GDPR, as applicable.
• Support the implementation of strategies adhering to FDA cGMP and EU Annex 21 regulations, including 21 CFR Part 11, 210, and 211 (ERES, Data Integrity, ALCOA), and Annex 1 and 11 regulations.
• Other related duties as assigned.

EDUCATION and/or EXPERIENCE

Bachelor’s degree in Information Systems, Computer Science or related technical degree from a credited college and six years of systems development, administration or related experience within the biopharma environment or an 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