Advanced Research Associate - Chemistry

Role Summary

Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for developing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to research in a laboratory environment.

Responsibilities

• Assist in the development new products or methods, or optimize or refine current product lines.
• Create new products using approved procedures and keep detailed and accurate records.
• Prepare summary reports for Feasibility, Development, and Transfer as required.
• Perform in-process analyses and determine adjustments to bring analytes into specification
• Analyze products, stock solutions, and raw materials using automated and manual instrumentation
• Evaluate that the analysis instrumentation and procedure is operating correctly, and verify or perform maintenance before use
• Measure accurately quantities of material volumetrically and gravimetrically, employing knowledge of chemical and biochemical properties and handling procedures
• Continually evaluate and/or create work instructions, QCRs, SOPs and other documents and procedures for effectiveness and modify through formal change process.
• Perform processing steps as required in the documentation such as centrifugation, diafiltration, in-process filtration, and column separation
• Perform final release testing
• Perform aseptic procedures such as, filtration, filling, capping and microbial plating
• Assist in training personnel in manufacturing procedures
• Assist in the validation testing of equipment and processes
• Perform assay testing for Value Assignment as required
• Assist in new product transfer and with the development of any new procedures required
• Assist in developing ways to increase efficiency and/or reduce costs
• Assist with overall maintenance and cleanliness of the laboratory and equipment
• Special projects as assigned
• Perform additional functions as required

Qualifications

• Required: Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field, with 1–5 years of work experience in In Vitro diagnostics, medical device, pharmaceutical, or related industry.
• Preferred: Additional years of relevant experience in developing products or methods and in performing analytical and quality control activities.

Skills

• Analytical techniques and instrumentation (automated and manual)
• In-process analysis and quality control
• Documentation, data recording, and reporting
• Aseptic techniques and microbial handling
• Equipment validation and maintenance
• Process development and transfer

Education

• Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field