Senior Manager, Analytical Development

Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products

Involvement in reference standard management and stability oversight

Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch preferred

Experience in support of late stage / commercial products including product monitoring, improvement and issue resolution preferred

Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers to ensure the company’s objectives are achieved

Fluid and conversant with GMP and quality control

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

$140,000

is experienced in working closely with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug

and drug product services to the pharmaceutical industry.  Working closely with Praxis’ CDMO network, the individual will use his or her knowledge of analytical method development, qualification, validation, and testing to support analytical projects across the portfolio.  Strong collaboration with Drug Substance/Drug Product scientists, engineers,

and manufacturing will be needed to ensure our products and processes are efficient and well-controlled.

Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members and functional leads.  This includes management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products and may include review of raw data, calculations, method validation documents, and stability reports; authoring analytical methods, CoAs, and reports; documenting, implementing, and monitoring change controls.

Oversight and coordination of CMC stability and reference standard programs.

Direct monitoring of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency.

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