Manager, GMP Quality Assurance (CONTRACT) at Abata Therapeutics

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

Analytical and detail oriented
Thrive in a fast-paced collaborative environment
Ability to manage multiple projects concurrently
Ability to review and analyze quality issues quickly to provide robust and timely solutions
Dependable and accountable for work
Excellent team player and relationship builder

Responsibilities

Support critical manufacturing and laboratory investigations, PPQ strategy development, and regulatory interactions, ensuring a strong quality process and inspection readiness
Lead or support preparatory work for Health Authority inspections and actively support inspection interactions
Review and approve master and executed batch records, ensuring final disposition compliance with regulatory filings and internal specifications where applicable
Review in-process, release, and stability data
Disposition lots from intermediates through finished drug product
Support internal and external deviations, change controls, and CAPAs to closure
Monitor evolving regulatory requirements and quality trends to ensure GMP Quality readiness and proactive compliance planning
Support Vendor Management Program, including management of vendor audit activities and the Approved Supplier List
Write and implement changes to GMP Standard Operating Procedures
Deliver expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records
Perform the appropriate QA review/approval of SOPs, SOP-related documents, and Policies
Lead and support understanding and adoption of risk-based approaches and decision making
Interact with cross-functional teams across technical operations as a QA lead or resource
Support all GxP functions as needed

Skills

GMP

Quality Assurance

Batch Record Review

Drug Substance Disposition

PPQ

Commercial Launch

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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