The Research Associate II will provide analytical chemistry support in Impel’s Analytical & Translational Sciences group. Impel’s product development team is a technical, driven and highly-collaborative group focused on introducing the best products possible into the market. As a Research Associate II, this team member will contribute to product development through the development of methods for analytical testing of drug-device combination products and by carrying out routine stability testing on Impel’s products in development.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
- Hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but not limited to performing HPLC assay and related substances testing, dose and spray content uniformity, device performance testing, particle size distribution and other tests to characterize and demonstrate product performance.
- Conduct laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, UV-visible spectrophotometry, loss on drying, Karl Fischer, DSC, particle size distribution, and other analytical techniques as required.
- Conduct and troubleshoot analytical methods for testing raw materials and products.
- Follow protocols and methods for the transfer and/or qualification/validation of analytical methods as necessary for development of pharmaceutical products. Implement the method qualification/validation. Summarize the results in the lab notebook and reports.
- Maintain a laboratory notebook in high fidelity.
- Contribute to lab maintenance/housekeeping, documentation, and training tasks as necessary.
- Other general laboratory tasks as assigned.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree in Chemistry or related field with 2+ years of industry laboratory experience and hands-on experience conducting experiments with HPLC of small molecules
- Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems
- Knowledge of working in a GLP and GMP environment
- Execution of daily activities with extreme attention to detail and ownership
- Outstanding organizational skills, ability to manage and complete tasks on time
- Proven ability to adapt and respond to the needs of a growing organization conducting R&D activities; communication and interpersonal skills are emphasized
- Familiarity with Microsoft Office Suite and Internet based office applications
- Ability to understand complex instructions and carry out procedures complying with instructions
- Ability to record and tabulate data; meticulous record keeping in the laboratory notebook
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position will require periods of standing in a fast-paced laboratory area to assist in the completion of testing and maintenance. Periods will range from 15 min to several hours standing to fulfill tasks.
- Must be able to lift 40 lbs. Received shipments of solvents and pharmaceutical products in development will require storage and careful moving in the laboratory to avoid spills.
- The technician must be able to lift 4L bottles of solvent to pour from one vessel to another to prepare solutions. Spills are to be avoided to protect the safety of the technician and the laboratory staff.
- May be responsible to move items to assess inventory in busy laboratory area for potentially prolonged periods of time.
- Ability to use computer, telephone, and other office machines.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Carts and lifts are available to help as needed.
This is a fast-paced environment with moderate noise level.
Up to 10% travel is anticipated.