Manager, Analytical Sciences - Commercial

Manager, Analytical Sciences
- Commercial

United States
- Remote

Location:

This position may be performed remotely with travel to the Boston area as needed, and an expected 20-30% travel to CDMO sites, particularly during validation campaigns, critical investigations, and health authority inspections.

Praxis is hiring a Manager, Analytical Sciences to play a key role in ensuring the analytical readiness and ongoing quality of Praxis’ commercial portfolio. You’ll own and support analytical strategy across commercial manufacturing, helping ensure testing is executed in accordance with regulatory commitments while advancing lifecycle management of approved products.

You’ll partner closely with CDMOs supporting small molecule drug substance and drug product manufacturing, with responsibility for analytical methods, control strategies, data integrity, inspection readiness, and continuity of supply. Success in this role will require strong scientific judgment, a hands-on approach, and the ability to identify risks early and work cross-functionally to develop practical solutions.

• 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.

• 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…