Commercial Analytical Sciences Manager - Remote

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 115,000 - 140,000; Full time

Job summary

Praxis Precision Medicines is seeking a Manager, Analytical Sciences - Commercial. This remote US role requires travel to the Boston area and 20-30% travel to CDMO sites for validation campaigns and inspections.

You will lead analytical strategy for the commercial portfolio, manage method transfer, validation, lifecycle management, and TE approvals with cross-functional teams to ensure regulatory readiness and data integrity.

Qualifications

• 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 knowledge of small molecule drug substances and oral dosage forms and regulatory requirements.

Responsibilities

• Execute analytical strategies for commercial products ensuring methods, specifications and control strategies remain compliant.
• Lead method transfer, validation, and lifecycle management activities with risk identification and resolution.
• Support analytical activities for PPQ, CPV, commercial manufacturing, and stability programs with data quality and regulatory compliance.
• Review and approve analytical documentation including protocols, reports, specifications, CoAs, and audit trails.
• Manage analytical activities at CDMOs ensuring timely, compliant deliverables for release, supply, and inspections.
• Lead or support OOS/OOT investigations, deviations, CAPAs with root cause analysis.
• Assess analytical risks from manufacturing and supply changes; ensure impurity controls and lifecycle strategies.
• Contribute to regulatory submissions, APR/PQRs, and health authority responses.
• Serve as analytical SME, partnering with Quality, Regulatory, Manufacturing, and CMC teams.

Skills

Analytical chemistry

GMP compliance

Method transfer

Validation

Data integrity

ALCOA+

cGMP knowledge

Regulatory submissions

Cross-functional collaboration

CDMOs management

Education

Bachelor’s degree in Chemistry or related discipline

Job description

Praxis Precision Medicines is seeking a Manager, Analytical Sciences - Commercial. This remote US role requires travel to the Boston area and 20-30% travel to CDMO sites for validation campaigns and inspections.

You will lead analytical strategy for the commercial portfolio, manage method transfer, validation, lifecycle management, and TE approvals with cross-functional teams to ensure regulatory readiness and data integrity.