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Security AnalystCapricor TherapeuticsSan Diego, California, United States

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Security Analyst

Capricor Therapeutics
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States

Über

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
We are seeking a detail-oriented Security Analyst to protect our cybersecurity operations within our regulated biotech/pharmaceutical environment. This role combines hands‑on security operations with compliance governance, focusing on protecting GMP systems, regulated data, and financially relevant systems in scope for SOX compliance.
This is a unique opportunity to work at the intersection of threat operations and regulatory compliance, ensuring adherence to GMP, SOX IT General Controls (ITGCs), and industry security frameworks while actively defending against evolving cyber threats.
Responsibilities
Monitor and Respond to Security Threats
Monitor, triage, and respond to security alerts across endpoint, email, and SIEM platforms
Investigate security incidents impacting:
GMP systems and regulated environments
SOX in-scope systems (financial applications, identity systems, etc.)
Execute incident response procedures aligned with validated and auditable processes
Maintain detailed, audit-ready documentation of all incidents and remediation actions
Manage Security Technology Stack
Administer and implement CrowdStrike Falcon for endpoint detection and response (EDR)
Manage Abnormal Security for phishing, business email compromise (BEC), and account takeover threats
Perform vulnerability assessments using Rapid7 InsightVM
Oversee KnowBe4 security awareness training and phishing simulations
Coordinate with SIEM platforms for log analysis and threat correlation
SOX IT General Controls (ITGCs)
Support SOX ITGC control execution and evidence collection, including:
User Access Reviews (UARs)
Logical access controls (joiner/mover/leaver processes)
Change management controls
Logging and monitoring controls
Prepare and maintain audit-ready documentation for SOX compliance testing
Coordinate with Finance and IT teams on control execution and remediation
Policy Development & Regulatory Compliance
Draft, review, and maintain information security policies, standards, and SOPs aligned with:
GxP requirements (GMP, GCP, GLP)
SOX IT General Controls
21 CFR Part 11 (where applicable)
NIST CSF, NIST 800-53, or CIS Controls
Ensure all policies are version-controlled, formally approved, and audit-ready
Partner with IT, Finance, QA, and Compliance to align controls across regulated and financial systems
Audit Support
Support internal and external audits including SOX, FDA, SOC 2, and regulatory inspections
Prepare control evidence and documentation packages
Track audit findings and coordinate remediation activities
Maintain relationships with internal audit and external assessors
Vulnerability Management
Conduct regular vulnerability scans across the environment
Prioritize remediation based on:
Regulatory impact (GMP systems)
Financial/reporting risk (SOX systems)
Threat landscape and exploitability
Coordinate remediation through appropriate change control processes
Track and document remediation evidence for compliance reporting
Security Awareness & Training
Administer security awareness training programs for all staff
Deliver targeted training for users with access to:
Regulated systems
Financial/SOX in-scope systems
Conduct phishing simulation campaigns and analyze results
Track training metrics and maintain compliance records
Continuous Improvement
Develop and maintain security playbooks, SOPs, and runbooks
Contribute to security metrics, KPIs, and executive reporting
Identify gaps in controls, detection capabilities, and governance processes
Recommend and implement security improvements aligned with business objectives
Requirements
Required Experience
Minimum 3 years of hands‑on cybersecurity experience
At least 2 years in a regulated environment (biotech, pharma, healthcare, or financial services)
At least 1 year supporting SOX ITGC controls or similar compliance frameworks
Demonstrated experience with security policy and SOP development
Technical Skills
Strong experience with Endpoint Detection & Response (EDR) platforms
CrowdStrike Falcon highly preferred, or equivalent (Carbon Black, SentinelOne, Microsoft Defender for Endpoint)
Hands‑on experience with vulnerability management tools
Rapid7 InsightVM preferred, or equivalent (Qualys, Tenable, Nexpose)
Experience with email security platforms
Abnormal Security, Proofpoint, Mimecast, or similar
Familiarity with security awareness platforms
KnowBe4 or equivalent
Working knowledge of SIEM tools and log analysis (Splunk, Microsoft Sentinel, or similar)
Compliance & Governance
Proven experience with SOX ITGC controls, including:
User access reviews and recertifications
Logical access provisioning and deprovisioning
Change management oversight
Audit evidence collection
Understanding of GMP (Good Manufacturing Practice) requirements and regulated system controls
Experience supporting security and compliance audits
Strong documentation and evidence management skills with an audit-ready mindset
Core Competencies
Exceptional attention to detail and commitment to process adherence
Analytical and investigative thinking for threat analysis
Strong written and verbal communication skills
Ability to translate technical security concepts for non-technical stakeholders
Proven collaboration skills across IT, Finance, QA, and Compliance teams
Self-motivated with ability to manage multiple priorities in a dynamic environment
Education & Certifications
Bachelor's degree in Cybersecurity, Information Technology, Computer Science, or related field
Security+ certification or equivalent
Advanced certifications such as:
CISSP or CISSP Associate
CISA (Certified Information Systems Auditor)
CySA+ (Cybersecurity Analyst)
GIAC Security Essentials (GSEC) or similar
Preferred Experience
Deep familiarity with 21 CFR Part 11 (electronic records and signatures)
Experience with additional security frameworks:
NIST Cybersecurity Framework (CSF)
NIST 800-53 controls
CIS Critical Security Controls
Prior experience supporting FDA inspections or pharmaceutical regulatory audits
Experience with SOC 2 attestation and controls
Basic scripting or automation experience (PowerShell, Python, Bash)
Experience with identity and access management (IAM) platforms
Familiarity with cloud security (Azure, AWS, or GCP)
$120,000 - $140,000 a year
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  • San Diego, California, United States

Sprachkenntnisse

  • English
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