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Manager, CMC Quality at Pulmovant - ApplyBlast

Manager, CMC Quality

Pulmovant

2 days ago

Remote

Full Time

Manager

0 applicants

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About this role

The Manager, CMC Quality supports quality oversight of Pulmovant's vendors to ensure drug substance, drug product, and finished product are manufactured, tested, and released in compliance with cGMPs. This individual contributor role focuses on batch record review and product disposition for the company's global clinical development program. The position requires a hands-on, detail-oriented professional comfortable working in a small-company environment.

Responsibilities

Lead batch record review and clinical lot disposition for drug substance and product
Oversee GMP Quality Systems activities at external partners including deviations and investigations
Support regulatory inspection preparation and ongoing inspection readiness activities

Skills

Qualifications

BA/BS degree in Chemistry, Biology, or Life Sciences

About Pulmovant

pulmovant.com

Headquarters

Waltham, Massachusetts, United States

Company Size

1-10 employees

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Pulmovant is a clinical-stage biopharmaceutical company singularly focused on developing innovative inhaled therapies for pulmonary diseases, including pulmonary hypertension. The company's lead candidate, mosliciguat, is a potentially first-in-class once-daily inhaled treatment with a differentiated soluble guanylate cyclase (sGC) activation mechanism. Pulmovant is advancing mosliciguat through clinical trials with the goal of transforming the treatment paradigm for patients with pulmonary diseases.