Manager, Analytical Method Validation

JOB REQUIREMENTS: Summary of Role The Manager, Analytical Method Validation is accountable for leading analytical method validation, verification, transfer, and lifecycle management activities in support of small molecule API development, technology transfer, and commercial manufacturing programs within a fast-paced CDMO environment. The incumbent provides technical and personnel leadership for the Analytical Method Validation group and is responsible for ensuring analytical methods are validated, transferred, and maintained in accordance with current regulatory expectations, client requirements, and internal quality standards. The position partners closely with R&D, Quality, Regulatory, Business Development, and Project Management teams to ensure successful execution of customer programs. Essential Functions * Provides leadership and technical oversight for analytical method validation, verification, qualification, transfer, and lifecycle management activities supporting development and commercial programs. * Develops and implements analytical validation strategies consistent with ICH, FDA, EMA, USP, and cGMP requirements. * Oversees execution and review of validation protocols, reports, method transfer packages, and supporting technical documentation. * Serves as the primary technical representative for analytical validation activities during customer meetings, project reviews, audits, and site visits. * Partners with Business Development and Project Management teams to support proposals, project scoping, technical assessments, and customer engagements. * Provides scientific leadership for troubleshooting analytical methods and resolution of complex analytical challenges. * Ensures data integrity, inspection readiness, and compliance with applicable regulatory and company requirements. * Reviews and approves SOPs, specifications, protocols, reports, validation packages, and controlled documents. * Provides direct supervision, coaching, performance management, and career development for Analytical Method Validation scientists and technical staff. * Participates in recruiting, interviewing, hiring, onboarding, and retention activities. * Develops, manages, and monitors departmental operating and capital budgets. * Evaluates and recommends investments in laboratory equipment, software, instrumentation, and personnel resources. * Manages project prioritization, laboratory workload, and resource utilization across multiple customer programs. * Builds and maintains strong customer relationships while ensuring high levels of scientific quality, communication, and customer satisfaction. * Identifies and implements continuous improvement initiatives. * Ensures timely completion and compliance with cGMP, safety, and all other relevant company training requirements. Key Competencies * Expert knowledge of analytical method development, validation, verification, transfer, and lifecycle management. * Advanced knowledge of HPLC, UPLC, GC, KF, FTIR, LC-MS, GC-MS, ICP-MS and related analytical techniques. * Strong understanding of ICH validation guidelines, cGMP requirements, and global regulatory expectations. * Demonstrated ability to lead validation strategies and defend analytical approaches during audits and inspections. * Demonstrated ability to lead, motivate, and develop high-performing scientific teams. * Strong business acumen with the ability to balance customer expectations, project priorities, resource utilization, and financial performance. * Demonstrated experience managing departmental budgets and capital expenditures. * Proven ability to build productive customer relationships and successfully represent analytical functions in client-facing environments. * Excellent written and verbal communication, negotiation, and influencing skills. * Demonstrated c To view the full job description please use the link below. https://www.aplitrak.com/?adid= mJnZW5lcmljLjAyMzgxLjg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAyMzgxLjg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ