Stability Coordinator

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

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E. standard to every program and relationship: Reliable, Outcome-driven, Scalable, and Excellent!

The Stability Coordinator is responsible for planning, coordinating, tracking, and documenting stability studies supporting drug substance, drug product, raw materials, reference standards, and packaging components throughout development, clinical, commercial, and lifecycle management activities. The role serves as the primary liaison between internal departments, clients, and analytical laboratories to ensure stability programs are executed in compliance with regulatory requirements, client expectations, and company procedures.

The Stability Coordinator maintains oversight of stability inventories, timepoint scheduling, sample management, data tracking, protocol execution, and reporting activities to support product development, regulatory submissions, product release, and ongoing market supply.

Why Rose BioSolutions

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.
• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
• Opportunities to grow your technical expertise and take ownership of your work.
• Close interaction with leadership and clients, enabling real influence on project outcomes.

Key Responsibilities

Stability Program Management

• Coordinate stability studies in accordance with approved protocols, project timelines, ICH guidelines, client requirements, and regulatory commitments.
• Create and maintain stability schedules for all active programs.
• Ensure stability studies are initiated, monitored, and completed according to established timelines.
• Track sample pulls, testing requirements, and protocol milestones.
• Monitor stability chamber occupancy and storage capacity.
• Coordinate study extensions, chamber transfers, and protocol amendments as required.

Sample Management

• Receive, inventory, label, and reconcile stability samples.
• Ensure proper storage conditions are maintained for all stability samples.
• Coordinate sample pulls at scheduled intervals.
• Prepare and distribute samples to analytical laboratories for testing.
• Maintain chain-of-custody documentation and sample accountability records.
• Investigate and resolve sample discrepancies.

Documentation and Data Management

• Generate and maintain stability protocols, sample inventories, tracking logs, and study reports.
• Verify data completeness and accuracy before report issuance.
• Maintain electronic and paper records in compliance with GMP requirements.
• Compile stability trend data and support data analysis activities.
• Ensure stability databases and tracking systems remain current and accurate.

Cross-Functional Coordination

• Serve as a primary point of contact between clients, Quality Assurance, Manufacturing, Analytical Development, Quality Control, Regulatory Affairs, and Project Management teams.
• Participate in project meetings and provide stability study status updates.
• Communicate upcoming testing requirements and sample pull schedules to laboratory personnel.
• Coordinate client requests related to stability studies and sample management.

Compliance and Quality

• Ensure stability activities comply with cGMP, FDA, EMA, MHRA, Health Canada, and ICH requirements.
• Support internal audits, client audits, and regulatory inspections.
• Assist in investigations related to out-of-trend (OOT), out-of-specification (OOS), and stability-related deviations.
• Initiate and support CAPA activities when required.
• Maintain training compliance and adherence to company procedures.

Reporting and Metrics

• Prepare routine stability status reports and client updates.
• Generate stability program metrics and key performance indicators.
• Support annual product reviews, quality reviews, and regulatory submissions.
• Identify scheduling risks and proactively communicate potential delays.

Qualifications and Experience

Education

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Quality Assurance, or a related scientific discipline preferred.

Experience

• 2-5 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments.
• Experience with GMP-regulated operations preferred.
• Familiarity with stability programs and sample management.
• Experience with laboratory information management systems (LIMS), stability tracking software, or quality management systems preferred.

Technical Knowledge

• Understanding of ICH stability guidelines (Q1A, Q1B, Q1D, and related guidance).
• Knowledge of cGMP requirements and pharmaceutical quality systems.
• Familiarity with analytical testing methods and stability-indicating assays.
• Understanding of regulatory filing requirements related to stability data.

Skills and Competencies

• Strong organizational and planning skills.
• Exceptional attention to detail.
• Ability to manage multiple projects simultaneously.
• Strong written and verbal communication skills.
• Client-focused mindset.
• Proficiency in Microsoft Office Suite, particularly Excel.
• Experience with electronic quality systems and data management platforms.
• Problem-solving and critical-thinking abilities.
• Ability to work independently and in cross-functional team environments.

COMPENSATION DATA:

The pay range for this position is $70,000 – $80,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.
• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.
• Competitive base salary with performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company contribution.
• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.