Associate Director/Director, Quality Control at Abata Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Expertise in providing quality control strategy, support, and oversight in a Phase 2 GMP biopharmaceutical manufacturing environment focused on monoclonal antibody production
Knowledge of analytical testing, raw material and in-process controls, method qualification and execution, release activities, and stability programs in compliance with cGMP, regulatory expectations, and internal quality standards
Ability to partner closely with CMC, Quality Assurance, Upstream/Downstream Process Development, Analytical Development, Supply Chain, Clinical Operations, and Regulatory Affairs
Willingness to travel 20-25% for on-site support with contract manufacturing and testing organizations
Capability to be in-office 3 days/week in a hybrid role in Waltham, MA
Passion for making a difference and contributing to an engaged, inclusive, and positive company culture

Responsibilities

Provide quality oversight of contract organization analytical testing, release testing, stability testing, microbiology, raw material release, and environmental monitoring programs
Participate in supplier qualification audits, due diligence site visits, and QC person-in-plant execution as needed
Facilitate investigations for out-of-specification and/or out-of-trend results, external deviations, product complaints, and coordinate necessary reviews and approvals
Oversee qualification, validation, and lifecycle management of analytical methods used to test monoclonal antibody products
Support tech transfer of analytical methods and establish relationships with contract manufacturing and testing organizations through on-site support
Provide leadership to execute scaling QC capabilities for future late-phase/commercial manufacturing needs
Manage external testing laboratories, stability programs, specifications, analytical methods, reference standards, and critical reagents programs
Develop phase-appropriate internal QC procedures and processes as pipeline continues to mature
Own and manage Oruka LIMS system and establish and manage QC-related metrics
Drive deviation investigations, out-of-specification (OOS) and out-of-trend (OOT) analysis, CAPA implementation, and change control within QC
Leverage stability data to project shelf-life of both DS and DP supply through trending analysis
Manage product expiration dates and expiry extensions
Ensure timely review, approval, and trending of QC data to support product batch disposition and regulatory compliance
Own QC-related regulatory submission content (e.g., IND amendments) and represent QC during audits and regulatory inspections

Skills

Key technologies and capabilities for this role

GMPcGMPQuality ControlMonoclonal AntibodiesAnalytical TestingMethod QualificationStability ProgramsCMCQuality AssuranceProcess DevelopmentRegulatory Affairs

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is hybrid in Waltham, MA, with candidates required to be in-office 3 days per week.

What is the salary or compensation for this position?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires expertise in GMP biopharmaceutical manufacturing for monoclonal antibodies, analytical testing oversight including method qualification and validation, stability programs, investigations for OOS/OOT results, and supplier qualification audits. Experience in Phase 2 clinical supply support and tech transfer of analytical methods is essential.

What is the company culture like at Oruka Therapeutics?

The company seeks top talent passionate about making a difference and eager to contribute to an engaged, inclusive, and positive company culture as they build their core team.

What makes a strong candidate for this position?

Strong candidates are those passionate about impactful work in biotech, with leadership experience in QC for Phase 2 GMP monoclonal antibody programs, and a drive to build robust internal QC infrastructure while partnering across CMC, QA, and other functions.

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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