Senior Director, Quality Assurance at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Central Nervous System DisordersIndustries

Skills

Key technologies and capabilities for this role

Quality AssuranceGxP ComplianceQuality Management System (QMS)GMPGLPGCPRisk AssessmentRegulatory InspectionsAuditsLot ReleasePharmaceutical ManufacturingPharmaceutical TestingPharmaceutical Release

Questions & Answers

Common questions about this position

What is the salary range for the Senior Director, Quality Assurance position?

This information is not specified in the job description.

Is this Senior Director role remote or does it require on-site work?

This information is not specified in the job description.

What key skills and expertise are required for this Senior Director, Quality Assurance role?

The role requires deep expertise in GxP compliance (GMP, GLP, GCP), Quality Assurance strategies, Quality Management Systems (QMS), regulatory inspections/audits, and cross-functional collaboration.

What is the company culture like at MapLight Therapeutics?

The company emphasizes leading a quality culture within the organization, driving continuous improvement, and fostering collaboration across cross-functional teams.

What makes a strong candidate for the Senior Director, Quality Assurance position?

Strong candidates will have senior-level expertise as a QA subject matter expert in GxP compliance, experience partnering with VP-level leadership, leading quality strategies across manufacturing and product lifecycle, and supporting regulatory submissions like IND and NDA.

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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