Manager, Analytical Sciences – Commercial

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

📋 Description

• Implement analytical strategies for commercial products, ensuring that methods, specifications, and control strategies are compliant and suitable for their intended purpose.

• Oversee method transfer, validation, and lifecycle management initiatives, identifying risks and driving resolutions.

• Assist with analytical activities for PPQ, CPV, commercial manufacturing, and stability programs.

• Evaluate and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis (CoAs), raw data, chromatographic integrations, and audit trails.

• Manage analytical operations at Contract Development and Manufacturing Organizations (CDMOs), ensuring compliant and timely deliverables that support product release, supply continuity, and readiness for inspections.

• Provide on-site assistance during critical campaigns and inspections.

• Lead or assist in analytical investigations involving out-of-specification (OOS) or out-of-trend (OOT) results, deviations, and Corrective and Preventive Actions (CAPAs), performing root cause analysis and supporting quality decisions.

• Evaluate analytical risks related to manufacturing, supply chain, and process modifications.

• Contribute to regulatory submissions, post-approval modifications, Annual Product Reviews (APR/PQRs), and responses to health authorities.

• Act as an analytical Subject Matter Expert (SME), collaborating with Quality, Regulatory, Manufacturing, and Chemistry, Manufacturing, and Controls (CMC) teams.

⛳️ Requirements

• Bachelor's degree in Chemistry or a related field.

• More than 7 years of experience in analytical chemistry within a GMP-regulated environment.

• Experience in supporting commercial small molecule drug substance and/or drug product initiatives.

• In-depth technical understanding of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.

• Familiarity with analytical method transfer, validation, and lifecycle management in GMP settings.

• Capability 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 supporting commercial analytical methods and control strategies, including post-approval changes and method enhancements.

• Proficient knowledge of US and EU cGMP regulations and relevant ICH guidelines.

• Ability to troubleshoot analytical testing challenges and collaborate with QC laboratories, CDMOs, and external service providers.

• Regular use of computers and other office equipment; effective communication skills; ability to move occasionally; comfort with screen work, basic hand coordination, and sustained focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision insurance plans.

• Company-sponsored life insurance, accidental death and dismemberment (AD&D) coverage, disability benefits, and optional plans.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays and company-wide shutdowns.