[Remote] Senior Director, Quality Control Analytical Sciences at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Drug DevelopmentIndustries

Requirements

Candidates must possess a PhD in a relevant discipline such as analytical biochemistry and have over 15 years of experience in Quality Control (QC) with complex biologics, specifically monoclonal antibodies, covering late-stage development and commercialization. A proven track record as a people leader with a growth mindset, dedication to psychological safety, excellent communication skills for diverse stakeholders, and experience with global regulatory filings are essential. The ideal candidate understands global regulatory guidance, can adapt to a fast-paced environment, is available for international calls, exhibits Apogee's C.O.R.E. values, and can travel up to 30%.

Responsibilities

The Senior Director, Quality Control (QC) Analytical Sciences will lead the QC Analytical Sciences team, overseeing QC activities for all pipeline programs. This includes developing strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing, as well as in-process/release/stability testing and specification justification. The role involves managing relationships with external QC testing labs and CDMOs, developing analytical regulatory strategies, preparing Module 3 regulatory documents, contributing to a mature QC infrastructure, and monitoring data trends to troubleshoot method performance and investigate OOT/OOS results.

Skills

Quality Control

Analytical Sciences

Method Qualification

Method Validation

Method Transfer

Drug Substance

Drug Product

Stability Testing

Specification Justification

Shelf-life Management

CMC Regulatory Strategy

Biologics

Antibody Engineering

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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