R&D Informatics Analyst

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DMT is a leading late‑stage biotechnology company advancing durable and disease‑targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The company’s lead product candidate 4D‑150 is designed to be a backbone therapy forming the foundation of treatment for blinding retinal vascular diseases by providing multi‑year sustained delivery of anti‑VEGF (aflibercept and anti‑VEGF‑C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections.

The company’s lead indication for 4D‑150 is wet age‑related macular degeneration, which is currently in Phase 3 development, and the second indication is diabetic macular edema. The second product candidate is 4D‑710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

In this role, you will work collaboratively within cross‑functional teams — including colleagues, consultants, vendors, and MSPs — and independently to support day‑to‑day operations and project‑based initiatives. The primary focus of the role is managing daily operational activities, including tier‑1 and tier‑2 IT helpdesk support for end users and customers. Responsibilities include supporting lab equipment and applications (GMP and non‑GMP), troubleshooting hardware and software issues, performing computer system validation activities (including change controls, validation execution, NCRs, AIRs, and CAPAs), maintaining data integrity and compliance, and administering system configuration, access management, security patching, and data backup processes.

The ideal candidate is adaptable, service‑oriented, and brings a broad technical skill set to effectively support evolving business needs. A hybrid schedule is acceptable with a desire to work 3–4 days onsite weekly.

• Execute & comply with 4
  
  DMT SDLC, change, access, inventory, and operational management procedures for business‑critical applications and platforms.
• Support evaluation, pilot testing, selection, and ongoing management of IT vendors and partners aligned to business and compliance requirements.
• Lead or support validation of computerized systems and laboratory instruments, including installation, configuration, troubleshooting, and documentation (SOPs, IQ/OQ/PQ).
• Ensure ongoing data integrity, backup, and regulatory compliance for GMP laboratory and manufacturing systems.
• Provide technical input and support for investigations, change controls, CAPAs, decommissioning, and audit readiness activities.
• Participate in or lead periodic reviews, user access reviews, and audit trail reviews for GMP systems.
• Execute and support UAT activities, collaborating with IT and business teams on issue resolution.
• Deliver hands‑on operational support for QC and manufacturing instrument systems, including break/fix support and reliability issues in validated and production environments.
• Manage user account provisioning and deactivation in compliance with access control SOPs.
• Other duties as assigned.

Education:

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field with at least five years of relevant experience in a laboratory environment or biotech/pharma setting; or
• Master’s degree with three to five years of relevant experience.

Experience:

• Strong operational knowledge of laboratory IT environments, including instrument connectivity and client/server architectures.
• Proficiency in Windows OS administration (registry, system files, security, local accounts & policies).
• Working knowledge of network technologies (VLANs, firewalls, security protocols, instrument LANs).
• Familiarity with virtualization platforms (e.g., VMware, Citrix VDI).
• Experience supporting validated systems in a regulated GxP environment is required.
• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process.
• Familiarity with a broad range of lab instrumentation and enterprise IT solutions used in biopharma, e.g., LC systems…