[Remote] CMC Project Manager at Abata Therapeutics

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

Bachelor’s degree in scientific or engineering discipline
Hands-on experience with sample management, including logistics, shipping, tracking systems, and compliance with GxP requirements
Strong project management skills with the ability to manage multiple priorities in a dynamic start-up environment
Excellent communication (verbal and written) and interpersonal skills; proven ability to engage with diverse stakeholders
Proficiency in project management tools (e.g., MS Project, Smartsheet, or equivalent)
Strong problem-solving skills with a collaborative and solutions-oriented approach
High level of organizational and time management skills
Ability to work collaboratively and effectively with cross-functional teams and external partners
Experience with regulatory and quality requirements, particularly in the pharmaceutical or biotechnology industry
Ability to maintain confidentiality and handle sensitive information

Responsibilities

Support CMC and technical operations teams to ensure deliverables are completed on schedule, within scope and budget, and aligned with program goals
Own sample management processes, including tracking, shipment, inventory control, and documentation in compliance with regulatory and quality requirements
Coordinate cross-functional project teams, including analytical, process development, manufacturing, quality, regulatory, and supply chain functions
Develop and maintain detailed project plans, timelines, dashboards, and status reports
Facilitate effective communication between internal teams and external partners (vendors, CMOs, and CROs)
Work collaboratively with PMs across functions to identify process improvements, optimize resource planning, and risk mitigation strategies
Proactively identify risks, issues, and dependencies, and escalate appropriately with mitigation recommendations
Support the preparation of project documentation, including meeting agendas, minutes, and decision logs
Track and report progress against milestones to senior management and program leadership

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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