Director Analytical Services

The Director of Analytical Services is responsible for the strategic and operational leadership of the Analytical Services Laboratory, including oversight of laboratory personnel, resource planning, and execution of analytical activities supporting development programs and commercial products.Specifically, Director of Analytical Services is responsible for overall management of the Analytical Services Laboratory including supervision of laboratory personnel, management of department budget, assignment of projects, and management of laboratory resources to meet analytical project development and method validation/transfer timelines, as well as commercial quality testing requirements. The Director of Analytical Services serves as a key customer and quality contact for all analytical related items in support of new product development activities and commercial product testing.This role is accountable for delivering a high-performance laboratory operation defined by efficiency, throughput, data integrity, and professional output, while ensuring timely execution of analytical development, method validation/transfer, and commercial quality testing.The Director serves as the primary operational and technical point of contact for customers beginning with project proposal support for all analytical activities and pricing. Following the engagement of the new customer, the Director is responsible for leading onboarding, execution, and ongoing communication to ensure a high-quality and predictable client experience.

Responsibilities

Leadership & Execution:Lead and oversee all analytical testing activities for development and commercial productsServe as primary technical and operational contact during onboarding and execution phasesQuality and Compliance:Ensure compliance with all GMP regulationsOversee investigations to ensure a thorough conclusive closure of the investigationEnsure appropriate CAPA’s are drafted and implemented in a timely mannerKnowledge of EU/ROW regulatory aspectsData Integrity:Ensure strong data integrity and right-first-time executionTechnical Oversight:Ensure resources for all testing (RM, in-process, finished product, validation, stability and Development)Laboratory Operations:Ensure compliance, inspection readiness, and proper lab conditionsCross-Functional Collaboration:Partner with Quality, Manufacturing, MS&T, Regulatory, Supply Chain, Engineering in coordination with Regulatory and Development manage and oversee CMC authoring for internal and customer regulatory filingParticipate in compiling regulatory responses for any regulatory requestsTraining & Organization:Build scalable organization and training systemsEnsure SOP, safety, and cGMP complianceClient Experience:During new customer engagement provide accurate details based on project scope analytical services activities and pricingOwn customer onboarding and communicationAct as escalation point for analytical issuesOperational Excellence:Drive throughput, efficiency, and predictabilityEstablish and Manage KPIs including TAT, on-time delivery, backlog, productivityFinancial & Resource Management:Manage budget with focus on efficiency and resource utilizationSupport financial performance through efficiency improvements

Qualifications

Advanced degree with 12–15+ years of experience in GMP analytical labs8–10 years leadership experienceStrong analytical/Scientific knowledge and BackgroundCDMO or contract lab experience preferredKnowledge in polymer E&L in drug finished dosage preferredStrong knowledge of cGMP and data integrity (FDA, EU etc.)Experience with LIMS systems and effective laboratory planningExperience with KPIs, capacity planning, and efficiency improvementsStrong leadership and communication skills with ability to participate in and contribute to a team-oriented work environment by developing positive working relationships with other departments