Associate Director, QC Data and Materials Management

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, BiologicsIndustries

Requirements

Candidates should possess a BS or advanced degree in a relevant discipline such as analytical chemistry or biochemistry, with over 10 years of experience in QC operations, systems, or analytical support roles within the biotech industry. A strong understanding of analytical techniques for monoclonal antibody release and stability testing, experience managing relationships with external analytical test sites, and knowledge of quality systems, cGMP regulations, and biopharmaceutical manufacturing standards are essential. The ideal candidate must also demonstrate effective prioritization, project management, and strong written and verbal communication skills, along with the ability to exhibit Apogee's C.O.R.E. values.

Responsibilities

The Associate Director, QC Data and Materials Management will oversee QC critical reagents and reference standards throughout their lifecycle, ensuring synchronization of change management across multiple vendor sites. This role involves performing technical reviews of vendor-provided material qualification and re-evaluation data, coordinating QC material and sample shipments, and authoring controlled documents for QC systems. Additionally, the position is responsible for LIMS system administration, including managing system changes, master data updates, workflow configurations, and supporting computer system validation and change control activities in partnership with the QA team and SaaS providers, as well as managing stability protocol configurations.

Skills

QC Data Management

Materials Management

LIMS Administration

Critical Reagent Management

Reference Standard Management

GMP Laboratory Operations

Biologics Manufacturing

Stability Study Management

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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