R&D Systems Analyst

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Candidates should possess a Bachelor's degree in Life Sciences, Information Systems, Engineering, or a related field, or equivalent professional experience. A minimum of 5 years of experience supporting IT systems or business processes within a biotech, pharmaceutical, or regulated life science environment is required, along with direct hands-on experience implementing technical solutions such as workflows and reports.

Responsibilities

The R&D Systems Analyst will partner with business teams to define business processes and user requirements, support project scope and deliverables, and troubleshoot technical and system/process issues. Responsibilities include managing change controls, overseeing vendor resources, acting as a liaison across R&D teams, and participating in the authoring, review, and execution of implementation plans and qualification tests. The role also involves supporting system enhancements, triaging requests, managing backlogs, and liaising with vendors and IT partners for implementation activities.

Skills

R&D Systems Analysis

IT Enterprise Applications

Clinical Operations

Clinical Development

Quality Assurance

Regulatory Affairs

Biometrics

System Optimization

Business Process Optimization

System Change Control Management

Computer System Validation (CSV)

GxP-regulated environment

Clinical Trial Management Systems

Health Authority Submissions

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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