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 products
  • Serve as primary technical and operational contact during onboarding and execution phases
• Quality and Compliance:
  • Ensure compliance with all GMP regulations
  • Oversee investigations to ensure a thorough conclusive closure of the investigation
  • Ensure appropriate CAPA’s are drafted and implemented in a timely manner
  • Knowledge of EU/ROW regulatory aspects
• Data Integrity:
  • Ensure strong data integrity and right-first-time execution
• Technical Oversight:
  • Ensure resources for all testing (RM, in-process, finished product, validation, stability and Development)
• Laboratory Operations:
  • Ensure compliance, inspection readiness, and proper lab conditions
• Cross-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 filing
  • Participate in compiling regulatory responses for any regulatory requests

• Training & Organization:
  • Build scalable organization and training systems
  • Ensure SOP, safety, and cGMP compliance
• Client Experience:
  • During new customer engagement provide accurate details based on project scope analytical services activities and pricing
  • Own customer onboarding and communication
  • Act as escalation point for analytical issues
• Operational Excellence:
  • Drive throughput, efficiency, and predictability
  • Establish and Manage KPIs including TAT, on-time delivery, backlog, productivity
• Financial & Resource Management:
  • Manage budget with focus on efficiency and resource utilization
  • Support financial performance through efficiency improvements