We are seeking a highly skilled and motivated scientist to join COUR and perform method development and optimization for COUR nanoparticle programs focusing on protein characterization and analysis. COUR 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. This role will involve supporting research, non-GMP, and Phase I/II GMP manufacture of COUR nanoparticles and associated drug substances, so adherence to and understanding of COUR quality guidelines and regulatory guidance is essential.
You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
- Execute routine and advanced QC assays for particle characterization.
- Optimize existing analytical methods and ensure methods translated from R&D are suitable for QC testing
- Execute analytical method optimization studies
- Design and execute method qualifaction and validation activies according to ICH Q2 (R1)
- Support R&D, non-GMP, and GMP characterization, release, and stability testing
- Author and review technical documentation, including but not limited to, protocols, standard operation procedures (SOP), work instructions, records, and reports
- Perform peer review of analytical test records
- Perform routine calibration, maintenance, and operation checks on laboratory equipment
- Execute and document all work according to COUR’s policies and procedures
- Work collaboratively with and support Development Lab and Quality teams.
- Bacheler’s or Master’s Degree in Biology, Chemistry, Bioengineering, Chemical Engineering, Biochemistry, or related field. Prior industry experience is a plus.
- Must be able to efficiently prioritize, manage, and complete multiple projects in a fast-paced environment.
- Must be proficient with a broad spectrum of analytical techniques applicable to particle-based drug delivery systems (e.g. particle size, plate-based assays, SEM, FTIR, mass spectroscopy, HPLC etc)
- Knowledge of FDA, cGMP, and ICH regulatory requirements is preferred.
- Must possess effective verbal and written communication skills.
If you describe yourself as an enthusiastic and highly motivated scientist and a great team player who wants to grow with us, we encourage you to apply! Please send resume and cover letter to: email@example.com
COUR is a rapidly growing biotech company in the Chicagoland area that develops therapeutics based on our deep knowledge of immunology and material science. Our team combines the skills and experience of biologists, material scientists, chemists, and engineers. COUR is expanding its laboratory and manufacturing capabilities at the Illinois Science + Technology Park, located at 8045 North Lamon Avenue in Skokie, Illinois. COUR is an Equal Opportunity Employer.