R&D Informatics Analyst (Contract)

Initial Therapeutics, Inc.; Emeryville (CA); Hybrid; USD 64,747 - 82,656; Full time

Job summary

Initial Therapeutics, Inc. is seeking an IT Operations Specialist to manage daily operational activities supporting lab equipment and applications. The ideal candidate will have extensive experience in lab IT environments, including both tier I and tier II support.

The position offers a hybrid work schedule, emphasizing compliance with regulatory standards and effective vendor management, requiring a bachelor's or master's degree in a related field.

Qualifications

• 5+ years of relevant experience in a laboratory environment or biotech/pharma setting.
• Strong operational knowledge of laboratory IT environments.
• Experience supporting validated systems in a regulated GxP environment.

Responsibilities

• Manage daily operational activities including IT Helpdesk support.
• Ensure ongoing data integrity and regulatory compliance.
• Support evaluation and ongoing management of IT vendors.

Skills

Operational knowledge of laboratory IT environments

Windows OS administration

Network technologies knowledge

Virtualization platforms familiarity

Experience supporting validated systems

Knowledge of regulatory requirements

Education

Bachelor's degree in Information Technology or related field

Master's degree with relevant experience

Tools

Lab instrumentation and Enterprise IT solutions

VMware

Citrix VDI

Job description

4DMT is a leading late‑stage biotechnology company advancing durable and disease‑targeted therapeutics that could transform treatment paradigms and benefit patients. Our lead product candidate, 4D‑150, is a backbone therapy designed to provide multi‑year sustained delivery of anti‑VEGF (aflibercept and anti‑VEGF‑C) with a single, safe intravitreal injection, substantially reducing the treatment burden associated with current bolus injections. 4D‑150 is currently in Phase 3 development for wet age‑related macular degeneration, with a second indication in diabetic macular edema. The second product candidate, 4D‑710, 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.

GENERAL SUMMARY

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 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. Hybrid schedule acceptable with a desire for 3‑4 days onsite weekly.

MAJOR DUTIES & RESPONSIBILITIES

• Execute & comply with 4DMT SDLC, Change, Access, Inventory, & operational management procedures for business‑critical applications & platforms.

• Support evaluation, pilot testing, selection,& ongoing management of IT vendors & partners aligned to business & compliance requirements.

• Lead or support validation of computerized systems & laboratory instruments, including installation, configuration, troubleshooting, & documentation (SOPs, IQ/OQ/PQ).

• Ensure ongoing data integrity, backup, & regulatory compliance for GMP laboratory & manufacturing systems.

• Provide technical input & support for Investigations, Change Controls, CAPAs, decommissioning, & audit readiness activities.

• Participate in or lead Periodic Reviews, User Access Reviews, & Audit Trail Reviews for GMP systems.

• Execute & support UAT activities, collaborating with IT & business teams on issue resolution.

• Deliver hands‑on operational support for QC & Manufacturing instrument systems, including break/fix support & reliability issues invalidated for production environments.

• Manage user account provisioning & deactivation in compliance with access control SOPs.

• Other duties as assigned; nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS

Education:

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field with at least 5+ years of relevant experience in a laboratory environment or biotech/pharma setting; or

• Master’s degree with 3–5+ years of relevant experience.

Experience:

• Strong operational knowledge of laboratory IT environments, including instrument connectivity & 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 (Waters/Agilent), AKTA, SoftMaxPro, Geneious, ELN/LIMS (Sapio), Imaging Systems, Bioreactors, Plate readers, Sequencers, etc.

Travel: None

Physical Requirements and Working Conditions:

• Physical Requirements – Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Base salary compensation range: $47.00 – 60.00. The base salary compensation range and actual salary offered to the final candidate depend on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities