Job Details

Target PR Range: 23-33/hr DOE
 

Role Description:

The Specialist Stability is an individual contributor role that provides critical support to Product Quality Teams (PQTs) by managing stability programs for late-stage clinical and commercial products. You will serve as a primary author of regulatory filing sections, organize and analyze product quality and stability data, and support GMP inspections across sites.

This role requires strong expertise in GMP compliance, data management, and cross-functional collaboration. You will also contribute to business process improvements by authoring SOPs and supporting the development of electronic data management tools such as Spotfire and SHINY applications.

Roles & Responsibilities:

• Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)
• Author and maintain GMP technical documents and stability reports in compliant systems
• Provide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)
• Collate, review, verify, and archive GMP stability and product quality data
• Coordinate stability study starts and sample requests with global teams
• Participate in audits and inspections across multiple sites, ensuring readiness and compliance
• Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes
• Mentor and train staff, sharing expertise to strengthen team capabilities

Basic Qualifications and Experience:

• Doctorate Degree in a Life Sciences or Engineering discipline OR
• Master’s degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor’s degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience

Functional Skills:

Must-Have Skills:

• Thorough understanding of GMP requirements, US FDA, and ICH regulations
• Strong scientific data management and organizational skills with exceptional attention to detail
• Proven technical writing skills with ability to author regulatory-quality documents
• Ability to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)
• Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationships
• Proven ability to work independently and manage time-sensitive activities across teams
• Continuous improvement mindset with experience applying lean practices
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)

Good-to-Have Skills:

• Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulations
• Experience with authoring, assembling, and reviewing annual product reviews
• Expertise in GMP applications (Veeva, Spotfire, SHINY) and proficiency in MS Office (Word, Excel, PowerPoint, Teams)
• Experience collaborating across time zones in a global, matrixed team environment

Soft Skills:

• Strong analytical and problem-solving mindset
• Strong initiative and self-motivation to drive results under pressure
• Ability to work independently and balance multiple priorities while meeting challenging deadlines
• Team-oriented approach with a focus on achieving shared goals
• Strong presentation and public speaking skills for inspections and cross-team updates

*CO/NYC candidates might not be considered