What are the responsibilities and job description for the Senior Operations Specialist 230 - Operations Skokie, IL position at Cour Pharmaceuticals Development Co., Inc.?
Senior Operations Specialist
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
Qualifications
230 - Operations
Skokie, IL
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.
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.
230 - Operations
Skokie, IL
