Commercial Analytics Leader — Remote with Travel

Praxis Precision Medicines, Inc.

United States

Remote

USD 147,000 - 167,000

Full time

14 days+

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Job summary

Praxis Precision Medicines seeks a Senior Manager, Analytical Sciences – Commercial to lead analytical testing for the commercial portfolio, ensuring regulatory compliance and robust data for product release and lifecycle management. You will oversee CDMO analytics, drive method transfers, validations, and CAPAs, and partner across QA, Regulatory, Manufacturing, and CMC to enable steady supply.

This role requires deep expertise in small-molecule analytics, cGMP, and regulatory inspections, with

Qualifications

Bachelor’s degree in Chemistry or 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.
Strong expertise in 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.
Demonstrated ability 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.

Responsibilities

Define and execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, robust, and fit for purpose.
Lead method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes.
Provide analytical leadership for PPQ, CPV, commercial manufacturing, and stability programs, ensuring reliable data, product quality, and regulatory compliance.
Review and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails.
Oversee analytical execution at CDMOs, ensuring timely, compliant deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections.
Lead analytical investigations involving OOS/OOT results, deviations, complaints, and CAPAs, driving root cause determination and technical recommendations consistent with FDA and EU GMP expectations.
Assess analytical risks associated with manufacturing, supply chain, and process changes, ensuring appropriate impurity controls and lifecycle management strategies are maintained.
Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.
Serve as the analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and informed decision-making.