[Hiring] Manager, Quality Operations, CMC @Praxis Precision Medicines, Inc.

Role Description

The Manager, Quality Operations, CMC is a key quality partner responsible for ensuring that Praxis medicines are manufactured, tested, controlled, released, and maintained to the standards our patients deserve. This role provides end-to-end Product Quality oversight across clinical development, launch readiness, and commercial operations, with a particular focus on drug substance, drug product, packaging, labeling, and external manufacturing partners.

• Provide end-to-end Product Quality oversight for assigned clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and associated contract service providers.
• Review and approve critical product and process documentation, including specifications, batch records, technical transfer documents, validation protocols and reports, stability documentation, and quality agreements.
• Lead the assessment and resolution of deviations, OOS/OOT and other atypical results, temperature excursions, change controls, CAPAs, and product quality complaints.
• Provide Quality oversight of contract manufacturers, laboratories, and other service providers, including vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution, and follow-up of observations and commitments.
• Lead or support product disposition activities for clinical and commercial batches, including release/reject decisions and coordination with Qualified Persons where applicable.
• Represent Product Quality on CMC, program, and external partner teams, providing strategic Quality input into product development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization.
• Partner across CMC, Regulatory Affairs, Supply Chain, and external organizations to anticipate and address quality risks, support IND/NDA filings and regulatory inspections, and build scalable processes that enable inspection readiness, launch readiness, and reliable supply to patients.

Qualifications

• 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.
• 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.
• 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%.

Requirements

• 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.
• Comfort with screen work, basic hand coordination, and focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• Annualized Base Salary: $117,000 — $137,000 USD

Company Description

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. 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, we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion.
• 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.