Senior Manager, CMC Analytical Chemistry

Job Purpose

The Senior Manager, CMC Analytical, is responsible for the execution and oversight of analytical development and quality control activities supporting late-stage development and commercial manufacturing. This role serves as the primary analytical lead for assigned programs and is accountable for the timely execution of analytical method development, validation, transfer, and quality control activities through internal and external partners. The incumbent will manage contract laboratories and manufacturing partners to ensure high-quality, compliant analytical deliverables that support product development, regulatory submissions, commercial supply, stability programs, and lifecycle management.

Responsibilities

• Serve as the analytical subject matter expert (SME) for analytical development and quality control activities supporting assigned programs.
• Manage and oversee CROs, contract testing laboratories, and CDMOs to ensure timely execution of analytical method development, validation, transfer, troubleshooting, and testing activities.
• Review analytical data, protocols, reports, and technical documents to ensure scientific quality, data integrity, and compliance with GMP and regulatory requirements.
• Provide analytical support to drug substance, drug product, and manufacturing teams to address development and commercial manufacturing needs.
• Execute analytical activities required to support regulatory submissions, post-approval changes, and lifecycle management.
• Prepare, review, and approve analytical protocols, reports, specifications, validation documents, and CMC sections of regulatory filings.
• Lead analytical change controls, deviations, laboratory investigations, and OOS/OOT investigations, ensuring timely resolution and implementation of effective CAPAs.
• Manage stability studies and reference standard qualification and requalification programs.
• Monitor analytical project timelines, identify risks, and drive issue resolution to maintain project and manufacturing schedules.
• Support quality audits, supplier audits, and regulatory inspections by providing analytical documentation and technical responses.
• Ensure analytical activities are conducted in compliance with current GMP regulations, ICH guidelines, internal procedures, and industry best practices.
• Contribute to continuous improvement initiatives to enhance analytical operations, documentation quality, and compliance performance.
• Support quality audit and health authority inspections.
• Strive for a collaborative, innovative, and results-oriented analytical development culture.

Qualifications

• Minimum BS degree in analytical chemistry, organic chemistry or related disciplines. Advanced degrees (e.g. MS, PhD) are preferred.
• 5+ years of relevant industrial experience in analytical development and/or Quality Control.
• Demonstrated experience independently managing analytical development and quality control activities for small molecule oral solid dosage form products through external laboratories and manufacturing partners.
• Strong experience in GMP change controls and OOS investigations.
• Experience managing projects at CROs/CDMOs.
• Working experience and knowledge of regulatory submission (IND, IMPD, and/or NDA).
• Effective written and verbal communication skills and interpersonal skills.
• Strong knowledge and understanding of current ICH guidelines, GMP guidelines, USP, EP, and related industry practices.
• Strong technical troubleshooting, problem-solving, and execution skills with the ability to make timely, data-driven decisions.
• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Ability to multi-task and thrive in a fast-paced innovative environment.