Senior GMP Operations Specialist (7+ YOE)

Senior Operations Specialist

About the Company

The company is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. The platform of immune-modifying nanoparticles aims to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression.

About the Role

We are seeking a highly skilled and motivated Operations Specialist to join the Operations Team. The company is a clinical-stage biopharmaceutical company located in Skokie, Illinois, with the goal of developing first-in-class innovative therapeutic products designed to reprogram the immune system to treat autoimmune disorders from pre-clinical development through FDA approval and commercialization. In this role, you will be responsible for supporting the Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.

You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:

Responsibilities

• Support the Operations team in drug substance and/or drug product manufacturing.
• Experience in new process implementation and continuous improvement.
• Help draft technical documentation for drug product and drug substance manufacturing.
• Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
• Experience leading Operations projects.
• Maintain manufacturing areas and process components to ensure a clean, safe, and organized work environment.
• Work collaboratively with and support the Development Lab and Quality teams.
• Follow standard operation procedures (SOP) and work instructions to execute tasks.

This role combines technical expertise, strategic leadership, and team management skills, ensuring the successful development and launch of injectable drug products.

Requirements

• Targeting 8-10+ years working in manufacturing or laboratory operations is required.
• Able to work in a clean room environment is required.
• Pharmaceutical or Medical Device industry experience is required.
• Knowledge of FDA, cGMP, and ICH regulatory requirements is required.
• Must be well organized, attentive to detail, and have effective verbal and written communication skills.
• Must be able to efficiently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment.

The level of this position will be based on the final candidate’s qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

BENEFIT OVERVIEW -

• Every employee receives shares!
• Competitive 401k benefit
• Annual target bonus