Pay Range: $30 to $38 – Depending on experience
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.
Summary
We are seeking an experienced Chromatography Process Development Scientist to provide hands‑on technical support for chromatography column manufacturing, packing, testing, and qualification processes. This role focuses on troubleshooting column performance issues, investigating manufacturing failures, optimizing packing parameters, and driving continuous process improvements. The ideal candidate will have a strong background in analytical chemistry and polymer chemistry, with hands‑on chromatography experience and a solid understanding of chromatography resins, silica stationary phases, and surface chemistry. The position requires close collaboration with Manufacturing, Engineering, Quality, and R&D teams to improve column performance, manufacturing reproducibility, and process efficiency.
Responsibilities
- Provide day‑to‑day technical troubleshooting support for chromatography column packing, testing, and qualification failures.
- Investigate chromatographic performance issues, including efficiency, peak asymmetry, resolution, retention, selectivity, backpressure, and flow behavior.
- Analyze chromatograms, pressure profiles, packing parameters, manufacturing records, and qualification data to identify root causes of column performance failures.
- Differentiate between failures associated with column packing, equipment, hardware, testing conditions, stationary‑phase properties, and manufacturing processes.
- Optimize column packing parameters, including packing pressure, flow rates, slurry conditions, equipment settings, and critical manufacturing variables.
- Design and execute experiments to improve column packing reproducibility, first‑pass yield, and manufacturing process robustness.
- Apply knowledge of polymer chemistry, chromatography resins, silica materials, and surface chemistry to investigate material‑related performance issues.
- Collaborate with Manufacturing Technicians, Subject Matter Experts (SMEs), Engineering, Quality, and R&D teams to resolve technical and manufacturing challenges.
- Document technical investigations, experimental findings, root cause analyses, and recommendations for process improvements.
- Develop, review, and revise Standard Operating Procedures (SOPs), work instructions, troubleshooting guides, and manufacturing documentation.
- Support training of manufacturing personnel on troubleshooting techniques, process improvements, and updated manufacturing procedures.
- Drive continuous improvement initiatives to enhance column quality, process reliability, and production efficiency.
Required Skills
- Bachelor's or Master's degree in Analytical Chemistry or Polymer Chemistry required.
- Minimum 3 years of relevant industry experience in chromatography, process development, analytical development, or manufacturing technical support.
- Working knowledge of polymer chemistry, including chromatography resins, silica stationary phases, and surface chemistry.
- Hands‑on experience with High‑Performance Liquid Chromatography (HPLC), Ion Chromatography (IC), or related chromatography systems strongly preferred.
- Experience troubleshooting chromatography columns, column packing processes, analytical instruments, or chromatographic performance issues highly desirable.
- Understanding of chromatography principles, including peak resolution, retention, selectivity, column efficiency, flow rates, and backpressure.
- Strong analytical skills with experience interpreting chromatograms, experimental data, and manufacturing performance metrics.
- Experience conducting root cause investigations, troubleshooting technical problems, and implementing process improvements.
- Knowledge of Design of Experiments (DOE), JMP, or statistical data analysis tools is an advantage.
- Experience working in GMP, ISO, or other regulated manufacturing environments preferred.
- Strong technical documentation skills, including preparation of investigation reports, SOPs, and work instructions.
- Excellent communication, problem‑solving, and cross‑functional collaboration skills.
- Ability to work hands‑on with manufacturing personnel, laboratory equipment, and production processes.
TekWissen Group is an equal opportunity employer supporting workforce diversity.