Senior GMP Stability Scientist & SME Lead

SHINE Technologies, LLC; Billerica (MA); Hybrid; USD 110,000 - 125,000; Full time

Job summary

SHINE Technologies, LLC is seeking a GMP Senior Stability Specialist to lead stability programs and ensure data integrity and regulatory readiness. The role requires on-site presence in Massachusetts and collaboration with QC, QA, Manufacturing, and Regulatory Affairs.

The ideal candidate has 5–8 years in GMP environments, a PhD/Masters preferred, and proven expertise in stability data interpretation, regulatory support, and continuous improvement of stability systems.

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences or related scientific field (Master’s preferred).
• Minimum 5-8 years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Experience with stability programs, QC laboratory operations, or analytical testing preferred.

Responsibilities

• Lead the design, implementation, and lifecycle management of complex stability programs for commercial, clinical, and development products.
• Serve as the Quality Control Stability SME during regulatory inspections, client audits, and internal audits.
• Independently assess stability data and provide recommendations on shelf-life, retest periods, and storage conditions.

Education

Bachelor’s degree in Chemistry or Pharmaceutical Sciences

Master’s degree preferred

Job description

SHINE Technologies, LLC is seeking a GMP Senior Stability Specialist to lead stability programs and ensure data integrity and regulatory readiness. The role requires on-site presence in Massachusetts and collaboration with QC, QA, Manufacturing, and Regulatory Affairs.

The ideal candidate has 5–8 years in GMP environments, a PhD/Masters preferred, and proven expertise in stability data interpretation, regulatory support, and continuous improvement of stability systems.