Analytical Method Validation Lead — Drive Validation Strategy

Sterling Pharma Solutions Limited; Town of Germantown (WI); On-site; USD 140,000 - 190,000; Full time

Job summary

Sterling Pharma Solutions Limited is seeking a Manager, Analytical Method Validation to lead validation, verification, transfer, and lifecycle management for small molecule API programs in a fast-paced CDMO environment.

You will provide scientific leadership, oversee validation documentation, and collaborate with R&D, Quality, Regulatory, and Project Management to ensure regulatory compliance and customer satisfaction. This role requires strong leadership and strategic thinking.

Qualifications

• Bachelor’s degree in a relevant scientific discipline with pharma exposure.
• Minimum 8 years in analytical development/validation or QC in pharma.
• 3–5+ years of direct people leadership experience.
• Experience authoring and reviewing validation documents in cGMP.

Responsibilities

• Lead validation, verification, transfer, and lifecycle activities for development and commercial programs.
• Develop validation strategies aligned with ICH, FDA, EMA, USP, and cGMP.
• Oversee validation protocols, reports, and method transfer packages.
• Represent analytics during customer meetings, audits, and site visits.
• Coach and develop analytical staff; recruit and retain talent.
• Manage budgets, equipment investments, and resource planning.
• Maintain data integrity and ensure inspection readiness.

Skills

Analytical method validation

Method transfer

Regulatory liaison

Team leadership

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

Empower

Chromeleon

LIMS

Job description

Sterling Pharma Solutions Limited is seeking a Manager, Analytical Method Validation to lead validation, verification, transfer, and lifecycle management for small molecule API programs in a fast-paced CDMO environment.

You will provide scientific leadership, oversee validation documentation, and collaborate with R&D, Quality, Regulatory, and Project Management to ensure regulatory compliance and customer satisfaction. This role requires strong leadership and strategic thinking.