Operations Specialist - The Steely Group

We are seeking a highly skilled and motivated Operations Specialist to join the Operations Team. The client 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.  
• Help draft technical documentation for drug product and drug substance manufacturing.
• Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
• 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.

Requirements / Qualifications:

• Experience working in manufacturing or laboratory operations is required.
• Able to work in a clean room environment environment is required.
• Pharmaceutical or Medical Device industry experience is preferred.
• Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
• 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.