IT Manager

Position Summary

Crystal Bio Solutions, a biologics-focused bioanalytical and analytical Contract Research Organization (CRO), is seeking an IT Manager to oversee and support the company’s U.S. site information systems operations. This individual will be responsible for managing day-to-day IT operations, infrastructure, and security while supporting the rapid growth of our organization. Candidates must have experience in IT operations within a biotech or CRO environment and be adept at managing complex projects and fast-paced growth. This role requires five days on-site presence at our Pleasanton, CA facility.

Key Responsibilities

IT Infrastructure and Operations

• Oversee the build-out and consolidation of office IT infrastructure, including on-premises servers, network systems, and equipment.
• Manage and maintain critical IT systems, including Microsoft 365, Zoom, wireless networks, printers, and other business applications.
• Support analysis, troubleshooting, diagnostics, and repairs for laptops, instrumentation, and equipment to minimize downtime.
• Streamline the IT onboarding process, ensuring new hires have the necessary tools, access, and equipment to be productive.

Compliance and Security

• Ensure compliance with GLP (21 CFR Part 58) and data integrity standards.
• Lead implementation of IT security measures, including physical, information, and cybersecurity policies.
• Develop and enforce IT standard operating procedures (SOPs), security awareness training, and internal IT audits.
• Manage compliance with 21 CFR Part 11 for electronic systems, ensuring secure, reliable, and auditable records and signatures.

Computer System Validation (CSV)

• Lead validation efforts for critical systems, including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and Electronic Lab Notebooks (ELN).
• Maintain validation documentation and ensure systems meet GLP and regulatory requirements.

Vendor and Stakeholder Collaboration

• Work closely with IT vendors, such as Pinnacle Solutions Inc., to develop robust support programs.
• Collaborate with internal departments to support their specific IT needs and align systems with business goals.

Leadership and Project Management

• Plan and execute IT projects, such as system upgrades, infrastructure improvements, and new technology implementations.
• Establish IT best practices and provide technical support to employees.
• Develop and manage yearly budgets, monthly allocations, and disaster recovery/business continuity plans.

Qualifications and Education Requirements

• Bachelor’s degree in computer science, Management Information Systems, or related technical field.
• 7+ years of related IT experience, with a minimum of 3 years overseeing IT operations in a biotech or CRO environment.
• Hands-on experience with system administration, infrastructure management, and IT security.
• Expertise in IT system implementation, maintenance, and integration.
• Proficiency in regulatory compliance for GLP (21 CFR Part 58) and electronic records (21 CFR Part 11).
• Experience with Computer System Validation (CSV) for laboratory systems like LIMS and CDS.
• Effective cross-functional collaboration and relationship building with stakeholders.
• Strong business acumen, including budget development and asset management.
• Ability to multitask, prioritize, and adapt in a fast-paced environment.
• Excellent written and verbal communication skills.

Position Summary

Crystal Bio Solutions, a biologics-focused bioanalytical and analytical Contract Research Organization (CRO), is seeking an IT Manager to oversee and support the company’s U.S. site information systems operations. This individual will be responsible for managing day-to-day IT operations, infrastructure, and security while supporting the rapid growth of our organization. Candidates must have experience in IT operations within a biotech or CRO environment and be adept at managing complex projects and fast-paced growth. This role requires five days on-site presence at our Pleasanton, CA facility.

Key Responsibilities

IT Infrastructure and Operations

• Oversee the build-out and consolidation of office IT infrastructure, including on-premises servers, network systems, and equipment.
• Manage and maintain critical IT systems, including Microsoft 365, Zoom, wireless networks, printers, and other business applications.
• Support analysis, troubleshooting, diagnostics, and repairs for laptops, instrumentation, and equipment to minimize downtime.
• Streamline the IT onboarding process, ensuring new hires have the necessary tools, access, and equipment to be productive.

Compliance and Security

• Ensure compliance with GLP (21 CFR Part 58) and data integrity standards.
• Lead implementation of IT security measures, including physical, information, and cybersecurity policies.
• Develop and enforce IT standard operating procedures (SOPs), security awareness training, and internal IT audits.
• Manage compliance with 21 CFR Part 11 for electronic systems, ensuring secure, reliable, and auditable records and signatures.

Computer System Validation (CSV)

• Lead validation efforts for critical systems, including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and Electronic Lab Notebooks (ELN).
• Maintain validation documentation and ensure systems meet GLP and regulatory requirements.

Vendor and Stakeholder Collaboration

• Work closely with IT vendors, such as Pinnacle Solutions Inc., to develop robust support programs.
• Collaborate with internal departments to support their specific IT needs and align systems with business goals.

Leadership and Project Management

• Plan and execute IT projects, such as system upgrades, infrastructure improvements, and new technology implementations.
• Establish IT best practices and provide technical support to employees.
• Develop and manage yearly budgets, monthly allocations, and disaster recovery/business continuity plans.

Qualifications and Education Requirements

• Bachelor’s degree in computer science, Management Information Systems, or related technical field.
• 7+ years of related IT experience, with a minimum of 3 years overseeing IT operations in a biotech or CRO environment.
• Hands-on experience with system administration, infrastructure management, and IT security.
• Expertise in IT system implementation, maintenance, and integration.
• Proficiency in regulatory compliance for GLP (21 CFR Part 58) and electronic records (21 CFR Part 11).
• Experience with Computer System Validation (CSV) for laboratory systems like LIMS and CDS.
• Effective cross-functional collaboration and relationship building with stakeholders.
• Strong business acumen, including budget development and asset management.
• Ability to multitask, prioritize, and adapt in a fast-paced environment.
• Excellent written and verbal communication skills.