Sr. Director, Analytical R&D

ClinLab Solutions Group - Boston, MA

Hiring: Sr. Director, Analytical R&D Company: ClinLab Solutions Group Location: Boston, MA Job Posted Time: 2026-09-10 12:53:52 Employment Type: Contract Target Skills & Keywords : AutoCAD, CAD, R, Regulatory Compliance About the job Experience: •15+ years of progressive industry experience in small molecule analytical development within pharmaceutical or biotechnology settings. Required Skills: •Direct analytical strategy and execution for small molecule programs across all development phases, ensuring alignment with overall objectives. •Develop and implement phase-appropriate analytical methods for drug substances and products, maintaining scientific rigor and regulatory compliance. •Manage and grow the analytical team, planning for future capability needs as the portfolio evolves. •Establish and maintain best practices for analytical lifecycle management, data integrity, and documentation. •Oversee outsourced analytical activities, including selection, onboarding, and performance management of external partners and laboratories. •Provide technical leadership in analytical method development, validation, and transfer using advanced chromatographic and spectroscopic techniques. •Ensure analytical methods and specifications are scientifically justified, phase-appropriate, and compliant with compendial and regulatory standards. •Partner cross-functionally with quality, regulatory, development, and clinical supply teams to ensure seamless integration of analytical activities into overall project plans. Qualifications: •MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline. •12–15+ years of progressive industry experience in small molecule analytical development within pharmaceutical or biotechnology settings. •Proven leadership in analytical development across multiple stages, including late-stage clinical and registration-enabling activities. •Expertise in chromatographic and spectroscopic techniques such as GC, LC, IC, chiral separations, and detection methods (UV/Vis, CAD, MS, fluorescence, FID, ECD). •Strong knowledge of global regulatory requirements and ICH guidelines for analytical development and control strategies. •Demonstrated ability to lead and influence cross-functional teams in a dynamic environment. •Excellent communication, collaboration, and scientific judgment skills. •Willingness to travel internationally up to 25% of the time. Compensation: •$250,000 - $280,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!