Note: The job is a remote job and is open to candidates in USA. Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. The Manager, Analytical Sciences will lead analytical strategies for commercial products, oversee method transfer, validation, lifecycle management, and analytical activities at CDMOs, and support regulatory compliance, investigations, product release, and inspection readiness.
Responsibilities
- Execute analytical strategies for commercial products, ensuring methods, specifications, and control strategies remain compliant and fit for purpose
- Lead method transfer, validation, and lifecycle management activities, identifying risks and driving resolution
- Support analytical activities for PPQ, CPV, commercial manufacturing, and stability programs, ensuring data quality and regulatory compliance
- Review and approve analytical documentation, including protocols, reports, specifications, method validations, CoAs, raw data, chromatographic integrations, and audit trails
- Manage analytical activities at CDMOs, ensuring compliant, timely deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections
- Lead or support analytical investigations involving OOS/OOT results, deviations, and CAPAs, performing root cause analysis and supporting quality decisions
- Assess analytical risks associated with manufacturing, supply chain, and process changes, ensuring appropriate impurity controls and lifecycle management strategies
- Contribute to regulatory submissions, post-approval changes, Annual Product Reviews (APR/PQRs), and health authority responses
- Serve as an analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations
Skills
- • Bachelor's degree in Chemistry or related discipline with 7+ years of analytical chemistry experience in a GMP-regulated environment
- • Experience supporting commercial small molecule drug substance and/or drug product programs; analytical development experience preferred
- • Strong technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products
- • Experience with analytical method transfer, validation, and lifecycle management in GMP environments
- • 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 supporting commercial analytical methods and control strategies, including post-approval changes and method improvements
- • Working knowledge of US and EU cGMP requirements and applicable ICH guidelines
- • Experience contributing to regulatory submissions and supporting health authority inspections preferred
- • Demonstrated ability to troubleshoot analytical testing issues and partner effectively with QC laboratories, CDMOs, and external service providers
- • 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
- • analytical development experience preferred
- • Experience contributing to regulatory submissions and supporting health authority inspections preferred
Benefits
- This position may be performed remotely with travel to the Boston area as needed
- 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
- Dollar-for-dollar matching up to 6% on eligible 401(k) contributions
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
- A phenomenal crew of colleagues who are smart, engaged and inspiring
Company Overview
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