Senior Manager, Analytical Sciences – Commercial

Role Overview

• 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.

Requirements

• 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.
• 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.

Benefits

• Diversity, Equity & Inclusion initiatives
• Professional development opportunities