Praxis Precision Medicines, Inc.
Senior Manager, Analytical Sciences - Commercial
United States - Remote · Senior
Sponsorship not specified$20k-$30kDetected 28 days ago
Supply ChainGMPFDA RegulatoryLeadershipCommunication
About the role
- Define and execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant, robust, and fit for purpose.
- 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.
Responsibilities
- Serve as the analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and informed decision-making.
- Lead method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes.
- 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.
Requirements
- Bachelor's degree in Chemistryor related discipline with 10+ years of relevant experience
- Master's degree with 7+ years of experience may be considered.
- Technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
- Working knowledge of US and EU cGMP requirements and applicable ICH guidelines, including impurity and mutagenic impurity guidance.
- 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.
- 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.
- 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.
Nice to have
- Experience supporting commercial small molecule drug substance and/or drug product programs
- analytical development experience preferred.
Compensation
- Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.
Benefits
- Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.
Company info
- 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.
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