Stability Program Lead

Piramal Pharma Limited; Pennsylvania; On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Stability Program Supervisor to lead the compliant and timely execution of the site Stability Program. The role reports to the Associate Director, QC Laboratory and supervises Stability personnel, coordinating cross-functional execution while maintaining inspection readiness and regulatory commitments.

You will oversee sample management, scheduling, testing coordination, data review, trends, investigations, and study closure, ensuring adherence to cGMP and

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.
• Minimum 5 years of pharmaceutical, biotechnology, or CDMO Quality Control experience, including direct stability-program experience in a cGMP laboratory.
• Experience coordinating stability studies, sample pulls, testing, data review, trending, reports, investigations, and study closure.
• Prior supervisory, team-lead, or program-lead experience strongly preferred.

Responsibilities

• Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.
• Maintain the Master Stability Schedule for study initiation, sample placement, pull dates, testing, review, reporting, and closure.
• Oversee sample receipt, reconciliation, labeling, storage, inventory, retrieval, transfer, and disposition with complete traceability.
• Coordinate cross-functional stability activities to meet regulatory commitments and customer requirements.

Skills

Leadership

Stability program

cGMP knowledge

Data review

Regulatory compliance

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or related scientific discipline

Tools

LIMS

Stability management systems

eQMS

Microsoft Office

Job description

Piramal Pharma Solutions is seeking a Stability Program Supervisor to lead the compliant and timely execution of the site Stability Program. The role reports to the Associate Director, QC Laboratory and supervises Stability personnel, coordinating cross-functional execution while maintaining inspection readiness and regulatory commitments.

You will oversee sample management, scheduling, testing coordination, data review, trends, investigations, and study closure, ensuring adherence to cGMP and