Director Analytical Services

THE RITEDOSE CORPORATION

About The Position

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.

Requirements

Advanced degree with 12–15+ years of experience in GMP analytical labs
8–10 years leadership experience
Strong analytical/Scientific knowledge and Background
Strong knowledge of cGMP and data integrity (FDA, EU etc.)
Experience with LIMS systems and effective laboratory planning
Experience with KPIs, capacity planning, and efficiency improvements
Strong 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

Nice To Haves

CDMO or contract lab experience preferred
Knowledge in polymer E&L in drug finished dosage preferred

Responsibilities

Lead and oversee all analytical testing activities for development and commercial products
Serve as primary technical and operational contact during onboarding and execution phases
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
Ensure strong data integrity and right-first-time execution
Ensure resources for all testing (RM, in-process, finished product, validation, stability and Development)
Ensure compliance, inspection readiness, and proper lab conditions
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
Build scalable organization and training systems
Ensure SOP, safety, and cGMP compliance
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
Drive throughput, efficiency, and predictability
Establish and Manage KPIs including TAT, on-time delivery, backlog, productivity
Manage budget with focus on efficiency and resource utilization
Support financial performance through efficiency improvements