Stability Program Lead – Pharma Compliance & Data

Rose BioSolutions; Rockville (MD); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Direct exposure to diverse client-proj

Collaborative, low-bureaucracy team

Job summary

Rose BioSolutions is seeking a Stability Coordinator to plan, coordinate, and document stability studies across development, clinical, and commercial programs. You will collaborate with internal teams, clients, and analytical labs to ensure timely, compliant stability activities and data integrity.

Responsibilities include maintaining stability inventories, scheduling timepoints, coordinating sample management, and generating reports to support product development, regulatory submissions, and

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Quality Assurance or a related scientific discipline preferred.
• 2–5 years of experience in pharmaceutical/biotech/CDMO environments; GMP-regulated operations preferred.
• Familiarity with stability programs, sample management, and regulatory expectations for stability data.

Responsibilities

• Coordinate stability studies per approved protocols, timelines, and ICH guidelines.
• Maintain stability schedules and monitor sample pulls and protocol milestones.
• Generate and maintain stability documentation, reports, and data accuracy.
• Serve as liaison between clients, QA, Manufacturing, and analytical groups.
• Ensure compliance with cGMP and regulatory requirements; support audits and CAPA activities.
• Prepare stability status reports and support regulatory submissions.

Skills

Organizational skills

Planning

Attention to detail

Multitasking

Written communication

Verbal communication

Client focus

Problem-solving

Independence/initiative

Education

Bachelor's degree in Chemistry or related field

Tools

MS Office Suite

Excel

LIMS

Stability tracking software

Quality Management Systems

Job description

Rose BioSolutions is seeking a Stability Coordinator to plan, coordinate, and document stability studies across development, clinical, and commercial programs. You will collaborate with internal teams, clients, and analytical labs to ensure timely, compliant stability activities and data integrity.

Responsibilities include maintaining stability inventories, scheduling timepoints, coordinating sample management, and generating reports to support product development, regulatory submissions, and