Praxis Precision Medicines, Inc. · 1 month ago
Senior Manager, Quality Operations, CMC
United States
Full-time
Remote
Mid, Senior Level
$100K/yr - $133K/yr
6+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Senior Quality Operations Manager, CMC is responsible for ensuring product quality and compliance throughout the manufacturing and testing processes, serving as the quality expert and making strategic decisions for the company's product pipeline.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
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
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints. Actively gathers necessary SME’s and leads team to resolve issues as applicable
Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities
Support vendor qualification program, review written reports, follow up to resolve findings, and monitor CSP performance
Development, maintenance, and review of clinical and commercial Quality Agreements
Act as Product Quality Lead in CMC, Program, and CSP team meetings to provide strategic direction and leadership to product development, registration, and approvals
Owns the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions are managed to conclusion
Direct the disposition (release/reject) activities interfacing with a QP where applicable
Ensure cohesive collaboration across CSPs for timely review of manufacturing records
Ensure robust processes are implemented for product management (e.g., control strategy, technology transfer, process validation lifecycle, quality monitoring)
Interface with Regulatory Affairs to review, and approve regulatory filings (IND, NDA)
Support pre-approval inspection and commercial readiness activities
Participate in hosting regulatory inspections, Support or perform internal and external audits
Qualification
Required
BA or BS degree in Chemistry or related field
6 + years in a GMP setting working with clinical and commercial products
Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA)
Proven track record and experience in supporting regulatory inspections (FDA, EMA)
Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products
Experience with disposition of product batches and interfacing with a QP and CSPs
Excellent written, organizational and oral communication skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
Ability to travel domestically and internationally to meet program needs (estimated 15-20%)
Preferred
Experience with product monitoring, complaint handling, issue resolution
Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment
Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all their forms
Highly organized and detail-oriented with a passion to deliver quality results
Benefits
99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
We match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives and ESPP.
Discretionary quarterly bonus
An extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns.
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-13
2026-01-11
Company data provided by crunchbase