Abata Therapeutics

Associate Director, Device Development

Remote

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries

Requirements

The Associate Director, Device Development should possess a strong understanding of biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This role requires experience working with external suppliers, manufacturers, and other functional areas within Technical Operations and Quality, ensuring the development and manufacture of high-quality combination products for clinical supply, commercial manufacturing, and regulatory submissions.

Responsibilities

As a technical leader, the Associate Director will provide technical leadership on cross-functional teams responsible for the development of combination products, working with the Quality function to develop and refine the combination product quality management system. They will author product-specific design control documentation, including User Requirements Specifications, Design Input Requirements, and Design Verification plans, protocols, and reports, oversee test method development, test method validation, and design verification at external labs, and establish human factors strategies while collaborating with human factors service vendors to execute formative and summative HF studies.

Skills

Biologic/device combination product development
Product design and development
Technology transfer
cGMP manufacturing oversight
Design control documentation
Test method development and validation
Design verification
Human factors strategies
Quality management systems

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.

Key Metrics

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.

Land your dream remote job 3x faster with AI