Associate Director, Formulation Development at Abata Therapeutics

Burlington, 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

Degree in Chemistry, Chemical Engineering, Pharmaceutical Science, Material Science or equivalent with commensurate experience (BS 12+, MS 8+, PhD 5+)
Experience managing drug product activities at external CDMOs
Experience in solid oral drug product development from preclinical to late phase clinical development
Strong understanding of solid oral dosage formulation technologies, processes and equipment
Knowledge of chemical and physiochemical techniques used to characterize drug products
Knowledge of cGMP and current quality and regulatory guidelines
Demonstrated ability to problem solve, think strategically, and effectively communicate in a fast-paced environment
Ability to self-motivate and work independently
Ability to travel up to 25% of time
Hybrid position with three days per week onsite at office in Burlington, MA

Responsibilities

Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3, including:
Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability
Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile
Design experiments to optimize the formulation and manufacturing process
Oversee formulation development and GMP manufacturing activities at CDMOs, including:
Lead DP IND section activities as necessary and manage vendor relationship
Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives
Drive review of batch records, protocols, reports, and other vendor documents
Provide technical expertise and guidance to troubleshoot development and manufacturing challenges
On-site presence for batch manufacturing activities at the CDMO as needed
Represent formulation development group in cross-functional teams and effectively communicate project status and technical risks with appropriate solutions
Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS
Author/review internal technical reports and drug product sections of regulatory filings
Participate and work effectively with multiple cross-functional teams
Demonstrate strong interpersonal skills, leadership, mentoring, and team player attitude

Skills

Formulation Development

Solid-Oral Dosage

API Characterization

GMP Manufacturing

CDMO Management

Drug Product Development

Pre-IND

Phase 3

Batch Records

Stability Testing

Manufacturing Process Optimization

Vendor Management

CMC

QA Collaboration

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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