GLP Systems Manager/LIMS Administrator

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This position is responsible for administering the Laboratory Information Management System (LIMS) and other Bioanalytical lab software. The role involves ensuring the effective implementation, validation, and ongoing maintenance of computer systems that support laboratory operations. The individual must possess extensive experience and strong leadership skills in managing computerized systems.

This role requires collaboration with IT, Quality Assurance, and laboratory personnel to ensure the software operates efficiently and smoothly. Additionally, this position requires an understanding of Good Laboratory Practice (GLP) regulations and relevant regulatory guidance to maintain compliance throughout the system's lifecycle.

Responsibilities include assessing system performance, troubleshooting issues, managing system upgrades, and implementing any necessary changes to align with evolving regulatory and user requirements. Strong problem-solving abilities and attention to detail are essential.

Responsibilities and Job Duties

LIMS and other Bioanalytical Software Administration & Computerized System Management:

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  • Oversee the daily operation, maintenance, and troubleshooting, including but not limited to the LIMS.
  • Manage system configurations, user access controls, and permissions in alignment with security policies and regulatory requirements.
  • Develop, implement, and maintain system workflows, templates, and automated processes to enhance efficiency in bioanalytical laboratory operations.
  • Serve as the primary point of contact for system and software related inquiries, user support, and issue resolution.
  • Configure, validate, implement Bioanalytical laboratory software and systems.
  • Plan and execute system upgrades, patches, and enhancements while minimizing operational disruptions.
  • Identify and implement process improvement initiatives to enhance system efficiency and user experience.
  
  
  
  

Regulatory Compliance, Validation & Data Integrity:

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  • Ensure compliance with Good Laboratory Practice (GLP) regulations, 21 CFR Part 11, and other applicable regulatory guidelines related to computerized systems.
  • Lead system validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
  • Write validation protocols, test scripts, and reports to support system implementation and ongoing compliance.
  • Maintain system documentation, including user requirements, validation protocols, risk assessments, and standard operating procedures (SOPs).
  • Ensure data integrity requirements are met for both current and new systems, in compliance with regulatory expectations.
  • Participate in regulatory inspections and audits, providing necessary system documentation and addressing findings.
  
  
  
  

Collaboration, Training & Leadership:

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  • Work closely with IT, Quality Assurance (QA), Validation, Project Management, Bioanalytical Laboratory personnel, and system vendors to diagnose, troubleshoot, and resolve system-related issues.
  • Gather and translate user requirements into system configurations and workflows to optimize laboratory operations.
  • Develop training materials and provide training sessions for end users software and systems functionalities, system updates, and compliance requirements.
  • Lead system-related projects, including new module implementation, integration with other laboratory instruments, and process automation initiatives.
  • Participate in the selection of new software, leading efforts in system and user requirement determination, risk assessment, and validation activities.
  
  
  
  

Minimum Qualifications

Education & Experience:

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  • Bachelor's degree in computer science, Information Technology, Life Sciences, Engineering, or a related field with 6+ years of related experience
  • Minimum of 4+ years of experience in an FDA-regulated environment, or 2+ years in an FDA-regulated environment with a relevant master's degree focused on computerized systems.
  • Hands-on experience as a LIMS administrator, including system validation, implementation, and integration with other computerized systems.
  • Strong understanding of 21 CFR Part 11, FDA GLP regulations (21 CFR Part 58), and ALCOA principles.
  • Familiarity with regulated laboratory operations, processes, and compliance requirements.
  • Experience in troubleshooting software issues and supporting IT operations in a bioanalytical laboratory.
  • Proficiency in Excel for data analysis and reporting.
  • Ability to work effectively in a fast-paced, team-oriented environment.
  
  
  
  

Preferred Qualifications:

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  • Experience in administering Watson LIMS and SoftMax Pro.
  • Understanding of large molecule assay validation and sample analysis testing.
  • Experience in leading and performing GxP software validations.
  • Knowledge of laboratory informatics systems and instrument integration.
  
  
  
  

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $118,900 - $181,300. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.