Senior Manager, Analytical Sciences - Commercial

• Bachelor’s degree in Chemistryor related discipline with 10+ years of relevant experience; Master’s degree with 7+ years of experience may be considered.
• Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred.
• Strongexpertisein analytical method transfer, validation, troubleshooting, and lifecycle management within GMP environments.
• Technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
• Demonstratedability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 requirements.
• Experience managing commercial analytical methods and control strategies, including evaluating and implementing method improvements.
• Working knowledge of US and EU cGMP requirements and applicable ICH guidelines, including impurity and mutagenic impurity guidance.
• Experience supporting regulatory submissions, post-approval changes, and health authority inspections; direct FDA or EMA inspection support experience preferred.
• Proven ability to build productive partnerships with CDMOs and external service providers while driving accountability and results.
• The physical and mental requirements of this role include regular use of a computer, mobile devices, and office equipment; clear communication; and occasional travel to laboratory, manufacturing, and office environments. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits 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!

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 and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.