[Remote] Associate Director, Analytical Development, Tech Ops (Biologics) at Abata Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

5+ years of experience in analytical development, preferably in the biologics industry
Proven track record of leading external method development, optimization and qualification/validation efforts
Experience in managing multiple non-GMP and GMP stability studies
Strong understanding of stability data trending analysis and shelf-life projection
Excellent leadership and collaboration skills
Experience in partnering with cross-functional stakeholders and internal and external stakeholders
Strong analytical and problem-solving skills
Ability to work in a fast-paced environment and prioritize multiple tasks
Experience in contributing to IND/BLA sections and CDMO vendor diligence
Strong communication and project management skills
Ability to travel 20-25% in support of diligence and campaign execution
Experience in managing confidentiality, master service, and contractual agreements

Responsibilities

Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials
Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs
Develop strategies to establish characterization and comparability packages across various DS/DP lots
Support process and manufacturing teams towards implementation of relevant analytical methods
Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material
Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications
Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results
Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability
Lead the diligence process to select clinical and commercial CDMO vendors
Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements

Skills

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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