Senior Manager, Analytical Development

Responsibilities

• Serve as an analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product (oral solids/liquids and other dosage forms) development and manufacturing at contractor sites
• Lead and support analytical development activities at multiple contractor sites related to analytical method development, method improvements, product characterization and comparability assessments for Harmony’s early and late-stage programs
• Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities:
• Serve as technical resource on drug substance and drug product aspects with particular emphasis in analytical chemistry and associated methodologies
• Provide oversight and serve as technical lead for the execution of method development, method improvement and method validation activities
• Manage laboratory deviations/investigations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony’s Quality function
• Oversee and co-manage release testing and stability programs for drug substance and drug product with Quality Assurance
• Ensure COs meet Harmony business objectives while meeting quality and compliance standards
• Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility
• Review and maintain lifecycle product documentation and data files related to analytical activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, etc.
• Work closely with the Project Manager and Contract Organizations (CMOs/CROs) to ensure all analytical deliverables are aligned and meet agreed project timelines. Apply Quality by Design (QBD) principles and Design of Experiments (DoE) to develop robust analytical methods. Trend, analyze, and statistically interpret stability data. Identify degradation pathways and variability drivers. Establish scientifically justified shelf-life projections
• Collaborate with other Harmony departments as required to:
• Achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients
• Define analytical testing strategy
• Develop and maintain technical aspects of quality agreements
• Lead the execution of analytical technology transfers, method implementation, qualification/validation
• Prepare and review dossiers for regulatory filings
• Drive fiscal responsibility with the operational budget and cost savings initiatives

Qualifications

• Bachelor’s degree in Analytical Chemistry (or related field) with 8+ years of relevant industry experience; Master’s degree with 5+ years of relevant industry experience; or PhD with 2+ years of relevant industry experience
• Technical Proficiency in analytical method development, including dissolution testing, chromatographic techniques (such as HPLC, and GC), and spectroscopy methods (such as UV-Vis, NMF, MS, along with expertise in method robustness and qualification/validation requirements)
• Experience managing a contract manufacturing organization (CMO) is a plus
• Knowledge and application of pharmaceutical analytical development principles, concepts, and industry practices to assist during audits or vendor inspections, and offer solutions to troubleshoot technical problems
• Experience in developing and transferring analytical methods from R&D to the commercial stage of the product lifecycle
• Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions
• Demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles (ICH, USP, and ISO standards), with particular emphasis on laboratory techniques and procedures
• Strong computer, organizational, and analytical skills required