Quality Operations Manager, CMC

Highly organized and detail-oriented with a passion to deliver quality results.

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary

$90,000

—

$107,000 USD

The Quality Operations Manager, CMC is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of drug substance and drug product for commercial and clinical distribution.

They serve as the quality expert for the Praxis pipeline of neurological disease product programs and is responsible for making strategic quality decisions throughout the product lifecycle end-to-end.

The incumbent will work with the CMC team executing clinical-stage development in support of clinical trials, launch readiness activities, and commercial quality operations.

Oversee the drug substance (DS), drug product (DP), reference standard, and packaging/labeling/serialization contract service providers (CSPs) for clinical-phase and commercial production activities

Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.)

Support stability program strategy including product shelf life and execution.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of

Trust

,

Ownership

,

Curiosity