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Job Title: Associate Research Scientist - Stability

Job Description

The Associate Research Scientist - Stability will provide scientific and technical support in the research and development of plasma-derived or recombinant proteins. This role supports the Stability Group by managing the stability program, ensuring compliance with regulatory standards, overseeing stability chambers, and maintaining product safety and quality for both licensed products and developmental projects.

Responsibilities

+ Maintain product inventory for active stability studies, ensuring accountability and compliance with all requirements.

+ Coordinate with Packaging to acquire samples for stability evaluation and ensure the accuracy of sample labeling and documentation.

+ Facilitate the delivery of stability samples for laboratory testing and resolve discrepancies in collaboration with QC Sample Specialists and stability supervisors.

+ Monitor and maintain label printers, ensuring they are in good working order for stability requests.

+ Track requests for additional samples and generate monthly pull schedules for stability testing.

+ Generate and manage work orders for maintenance and repairs of stability equipment to prevent product loss.

+ Ensure compliance with test request sheets and conduct investigations to resolve GMP discrepancies.

+ Enter test data into stability databases and assist with filing stability records.

+ Remove samples from inventory upon completion of stability studies and initiate purchase and work orders for the Stability Group.

+ Train staff on sample handling and inventory procedures, and perform daily assessments of stability incubators and freezers.

+ Investigate excursions outside validated temperature ranges and analyze chamber temperature and humidity trends.

+ Conduct reviews to ensure equipment compliance and address chamber concerns proactively.

Essential Skills

+ Understanding of ICH guidelines and GMP requirements for Stability product storage.

+ Excellent communication skills for generating clear, accurate reports and interacting with cross-functional teams.

+ Working knowledge of equipment and storage facility operations.

+ Ability to resolve chamber-related issues quickly and assess the impact of deviations.

+ Proficiency in ScienTek Stability System, labeling solutions software, Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System, and TempTale Monitoring Devices.

+ Experience in visual inspection and vial integrity testing, as well as biological sample shipment.

+ Basic calculation skills, attention to detail, and effective verbal and written communication skills.

Additional Skills & Qualifications

+ MS Degree or BS with 1-2 years of experience, or no degree with 5 years of experience relevant to the role.

+ Education in a scientific field or experience in the regulated pharmaceutical industry.

+ Technical expertise in separations-based analytical techniques such as HPLC, Capillary Electrophoresis, and SDS-PAGE.

+ Working knowledge of Waters Empower and proficiency in method development and qualification based on ICH guidelines.

Work Environment

The work environment includes clinical and laboratory settings with exposure to biological fluids, potential infectious organisms, and chemicals. Personal protective equipment such as protective eyewear, garments, and gloves is required. The position involves frequent sitting and neck bending, occasional standing and waist twisting, and hand movements. Moderate lifting of 15-30 lbs. is required. The role demands precise coordinated movements and the ability to communicate complex information effectively. The work involves collaborating with diverse groups to address complex issues and performing tasks with variable demands.

Job Type & Location

This is a Contract position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $37.50 - $41.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Durham,NC.

Application Deadline

This position is anticipated to close on Jan 8, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.