Operational Specialist

1 month ago


Skokie, United States Theery Full time

Our client is seeking a highly skilled and motivated Operations Specialist to join their Operations Team. Our client is a clinical-stage biopharmaceutical company 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 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.


Education, Qualifications and Experiences:

• 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.



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