[Remote] CMC Project Manager at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

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
Highly motivated team player

Responsibilities

Support CMC and technical operations teams, to ensure that 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 to ensure alignment and progress
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

Key technologies and capabilities for this role

CMCProject ManagementSample ManagementRisk ManagementBudget PlanningStakeholder ManagementDocumentation ManagementMeeting Facilitation

Questions & Answers

Common questions about this position

Is remote work allowed for this CMC Project Manager position?

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

What are the key skills required for the CMC Project Manager role?

The role requires experience in sample management, outstanding organizational and communication skills, and the ability to work collaboratively with cross-functional stakeholders and external partners.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Dianthus Therapeutics?

The company features a collaborative, cross-functional team environment and is building a culture centered on core principles to elevate patient care.

What makes a strong candidate for the CMC Project Manager position?

Strong candidates will have experience in sample management, excellent organizational and communication skills, and proven ability to coordinate cross-functional teams and manage CMC activities effectively.

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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