About COUR

COUR is a clinical stage biotech company with a mission to restore health in autoimmune patients by developing first-in-class, disease-modifying, targeted therapies to safely regulate and calm the immune system.  Our portfolio consists of three mid-to-late-stage proprietary programs: PBC, myasthenia gravis (MG), and type 1 diabetes (T1D), and our platform positions us to broaden our impact in antigen-specific autoimmune conditions.

About the role

We are seeking a highly skilled and motivated Operations Specialist to join the COUR Operations Team.

What you'll do

·        Support the Operations team in drug substance and drug product manufacturing for our clinical programs.

·        Lead various Operations projects, including new process implementation and continuous improvement initiatives.

·        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.

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

Qualifications

·        8-10 years working in GMP manufacturing or laboratory operations

·        Pharmaceutical or Medical Device industry experience and related knowledge of FDA, cGMP, and ICH regulatory requirements is required.

·        Ablility to work in a clean room environment

·        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.

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.