Stability Team Lead

About This Role

Lead and manage Quality Control stability programs for nasal spray medications, ensuring compliance with cGMP, SOPs, and ICH guidelines to protect patient safety and product quality.

Responsibilities

• Lead and manage all QC stability programs in compliance with cGMP, SOPs, and ICH guidelines
• Oversee stability study design, initiation, maintenance, and execution, including protocols, sample pulls, testing, and reporting
• Ensure stability chambers are properly maintained, calibrated, qualified, and utilized efficiently
• Review stability data, identify OOS/OOT results, and lead or support investigations as required
• Author, revise, and approve stability-related SOPs, protocols, and reports
• Perform data trending and interpretation of degradation and stability results
• Train and mentor team members on stability-related activities and best practices
• Serve as a client-facing subject matter expert for stability programs
• Drive continuous improvement initiatives to enhance stability operations and compliance
• Manage multiple projects and priorities to meet internal and client timelines

Requirements

• Bachelor’s degree in Chemistry or related field
• 5+ years of pharmaceutical industry experience
• Knowledgeable in ICH guidelines: Stability and Impurities
• Sound understanding of chromatography and degradation products testing
• Ability to multitask and adjust priorities
• Strong organizational skills
• Qualified to work with controlled substances

Qualifications

• Bachelor’s degree in Chemistry or related field
• At least 5 years of pharmaceutical industry experience; direct stability coordination experience may be considered in lieu of total years of experience

Skills

* Required skills