Manager, Quality Operations, CMC

• BA or BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline.
• 6+ years of progressive experience in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products.
• Strong working knowledge of GMP requirements and applicable FDA, EMA, ICH, and other global regulatory expectations, with demonstrated ability to translate requirements into practical, risk-based decisions.
• Experience supporting small-molecule drug substance and solid oral drug product manufacturing, including Quality Management Systems, QC operations, technical transfer, validation, stability, and product lifecycle management.
• Hands-on experience with batch disposition, deviations and investigations, change control, CAPA, OOS/OOT events, product complaints, and external manufacturing partners.

interfacing with Qualified Persons is strongly preferred.

• Experience supporting health authority inspections, pre-approval inspections, internal audits, and/or external supplier audits.
• Ability to travel domestically and internationally based on program needs, estimated at approximately 15–20%.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. 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.