Principal Scientist, Drug Substance Process 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 Synthetic Organic Chemistry or related discipline with relevant industry experience (PhD: 5+ yrs, MS: 10+ yrs, BS: 12+ yrs)
Proven track record of managing CRO/CDMO relationships and delivering on CMC milestones
Strong understanding of GMP manufacturing and ICH regulatory requirements
Excellent written and verbal communication skills
Demonstrated ability to manage multiple projects and priorities effectively
High attention to detail and commitment to scientific rigor
Strong team player with a collaborative mindset and ability to work effectively across disciplines
Ability to self-motivate and work independently
Flexibility to attend weekly calls, especially with CDMOs in different time-zones
Ability to travel up to 25% of time
Preferred Experience
Prior involvement in late-stage development and tech transfer activities
Familiarity with QbD principles and risk-based development approaches

Responsibilities

Lead the phase-appropriate development, scale-up, and optimization of cost-effective synthetic routes for small molecule drug substances intended for CNS therapeutics
Oversee and manage relationships with CROs and CDMOs to ensure timely and quality delivery of drug substance materials and data
Author and review CMC sections of regulatory filings including INDs, IMPDs, and NDAs. Ensure alignment with global regulatory expectations
Lead investigations and resolution of quality events (e.g., deviations, OOS, OOT). Collaborate with Quality Assurance to ensure compliance with GMP standards
Work closely with Analytical Development, Formulation, Regulatory Affairs, Drug Discovery, and Clinical Supply teams to support integrated development strategies
Drive timelines, budgets, and deliverables across multiple projects. Communicate progress and risks effectively to stakeholders
Prepare and critically review technical reports, protocols, and development summaries with high attention to detail
Foster a collaborative team environment and contribute to cross-functional problem solving and decision making
Promote technical excellence through mentoring, peer review, and continuous improvement initiatives

Skills

synthetic organic chemistry

process development

scale-up

CRO management

CDMO management

CMC

regulatory filings

IND

IMPD

NDA

GMP compliance

project management

quality investigations

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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