Senior Manager, Analytical Sciences – Commercial

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement analytical strategies for commercial products, ensuring that methods, specifications, and control strategies are compliant, robust, and suitable for their intended use.

• Lead activities related to method transfer, validation, and lifecycle management, identifying areas for enhancement and facilitating post-approval modifications.

• Provide analytical leadership for PPQ, CPV, commercial manufacturing, and stability initiatives, ensuring data reliability, product quality, and adherence to regulatory standards.

• Review and authorize analytical documentation, such as protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails.

• Supervise analytical operations at CDMOs, ensuring timely and compliant deliverables that support product release, supply continuity, and readiness for inspections, including on-site assistance during critical campaigns and audits.

• Lead investigations into analytical issues involving OOS/OOT results, deviations, complaints, and CAPAs, promoting root cause analysis and technical recommendations that align with FDA and EU GMP standards.

• Evaluate analytical risks related to manufacturing, supply chain, and process alterations, ensuring that suitable impurity controls and lifecycle management practices are upheld.

• Prepare and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.

• Act as the analytical Subject Matter Expert (SME), collaborating with Quality, Regulatory, Manufacturing, and CMC teams to support compliant commercial operations and facilitate informed decision-making.

⛳️ Requirements

• Bachelor’s degree in Chemistry or a related field with over 10 years of relevant experience; a Master’s degree with 7+ years of experience may also be considered.

• Experience in supporting commercial small molecule drug substance and/or drug product programs; analytical development experience is preferred.

• Strong proficiency in analytical method transfer, validation, troubleshooting, and lifecycle management within GMP environments.

• Technical familiarity with small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.

• Proven ability to review analytical data, chromatographic integrations, and electronic audit trails in compliance with ALCOA+, 21 CFR Part 11, and EU GMP Annex 11 standards.

• Experience in managing commercial analytical methods and control strategies, including assessing and executing method improvements.

• Working knowledge of US and EU cGMP regulations and relevant ICH guidelines, particularly concerning impurity and mutagenic impurity guidance.

• Experience in supporting regulatory submissions, post-approval changes, and health authority inspections; direct support experience during FDA or EMA inspections is preferred.

• Demonstrated ability to cultivate productive relationships with CDMOs and external service providers while driving accountability and results.

• The physical and mental demands of this position include regular use of a computer, mobile devices, and office equipment; effective communication; and occasional travel to laboratory, manufacturing, and office settings.

🏝️ Benefits

• Diversity, Equity & Inclusion initiatives

• Professional development opportunities