[Remote] Senior Manager, Biologics Analytical Research and Development at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience, advanced degree highly preferred
Demonstrated experience in analysis of biologics, including SEC, IEX, CE-SDS, CEIEF techniques, PCR, and cell-based potency assays and ELISA based assays
Prior experience with analytical method development for fusion proteins/ bi-specific antibodies is a plus
Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment
Strong working knowledge of analytical methodologies, Critical Quality Attributes/QbD/DOE principles, and data analysis and statistics for setting specifications
Ability to design and direct the development/qualification of release, characterization, and stability assays
Working knowledge of LIMS, Veeva, SAS and/or JMP is a plus
Working knowledge of quality systems, GMP, FDA, ICH, and EMEA guidelines for stability, especially in biologics

Responsibilities

Work collaboratively with the CMC organization to define strategies to solve complex analytical problems
Support activities related to clinical drug substance and drug product stability studies at various contract laboratories
Report to the Senior Director of Analytical Development and provide technology development, strategic leadership, and technical expertise
Work with and build strong collaborations with external CDMOs and CTLs
Collaborate cross-functionally to ensure the timely and successful development of pipeline drug candidates
Monitor contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database
Plan assay optimization and documentation to meet program deadlines
Deliver strong assay development and validation

Skills

Key technologies and capabilities for this role

Method DevelopmentOptimizationQualificationValidationProtein BiologicsAnalytical DevelopmentCollaborationLab Informatics

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the company is open to remote work for this role.

What are the minimum education and experience requirements?

A BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience is required, and an advanced degree is highly preferred.

What technical skills and techniques are required for this role?

Demonstrated experience in analysis of biologics is required, including Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE-SDS, CEIEF), PCR, cell-based potency assays, and ELISA-based assays.

What is the company culture like?

The company is building a culture of individuals who hold core principles at the center of operations to elevate patient care, within a small, clinical-stage biotech environment.

What makes a strong candidate for this Senior Manager role?

Strong candidates will have the required BS with 5+ years experience (advanced degree preferred), demonstrated biologics analysis expertise in key techniques like SEC, IEX, CE-SDS, and prior experience with analytical method development for fusion proteins or bi-specific antibodies.

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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