Made Scientific

Compensation

Full Description

About Made Scientific Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors. Position Summary The Security Analyst is responsible for safeguarding Made Scientific’s digital infrastructure, proprietary data, and regulated information—including GMP and client data—from internal and external threats. This role ensures compliance with industry standards such as GxP, FDA 21 CFR Part 11, ISO 27001, and other relevant cybersecurity frameworks. The analyst will monitor, assess, and strengthen security measures across manufacturing, R&D, and corporate systems. Key Responsibilities • Conduct regular vulnerability assessments and penetration tests on IT systems and OT (Operational Technology) used in manufacturing. • Manage access controls and identity management for ERP systems, Azure Cloud, O365, and Active Directory. • Ensure compliance with FDA, EMA, HIPAA (if applicable), and internal SOPs. • Support audits related to information security and data integrity. • Implement security monitoring tools using frameworks such as NIST. • Monitor network traffic, endpoints, and cloud environments for suspicious activity using SIEM tools. • Investigate and respond to security incidents, breaches, and anomalies. • Maintain and update incident response and disaster recovery plans. • Develop and enforce cybersecurity policies aligned with CDMO operations. • Conduct security awareness training for staff, focusing on data integrity and confidentiality in GMP environments. • Work with the Network Engineer to implement and maintain firewall policies. • Implement intrusion detection/prevention systems and endpoint protection. • Oversee secure configuration of laboratory and manufacturing systems (e.g., MES, LIMS). • Collaborate with QA, Regulatory Affairs, and IT teams to ensure secure handling of client IP and batch records. • Liaise with third-party vendors to validate security compliance. Required Qualifications • Bachelor’s degree in IT or a related field. • Minimum 5 years of hands-on experience in cybersecurity. • Knowledge of GxP compliance and data integrity principles. • Familiarity with security frameworks (ISO 27001, NIST). • Proficiency with SIEM tools, vulnerability scanners, and endpoint security solutions. • Experience with Microsoft tools and Azure environments. • Strong infrastructure security background (endpoint, network, systems). • Familiarity with security automation and scripting. • Strong collaboration and communication skills. Preferred Skills • Experience with cloud security (Azure/AWS) and OT cybersecurity. • Understanding of regulatory environments for CDMO operations. • Certifications such as CISSP, CISM, CompTIA Security+, or equivalent.