Research Associate / Sr. Research Associate

Job Description

Job Description

Description:

• Perform routine and novel analytical testing to support biological therapeutic products from early-stage development through late- stage/commercialization.
• Analytical methods may include, but not limited to: HPLC, reduced and nonreduced CE-SDS, icIEF, concentration by A280, and ELISA.
• Support Quality unit for GxP activities.
• Assist other functional groups to support cell line development, formulation development, and upstream/downstream process development studies.
• Participate in tech transfer, characterization, and comparability studies and analyze in-process and product-related impurities.
• Perform data analysis and troubleshooting of analytical methods as needed.
• Write, review, and edit SOPs and Test Methods for new products, instruments, procedures, and assays; review, edit and revise existing SOPs to reflect changes in procedures.
• Write technical development reports, characterization summaries, method development documentation, and give oral presentations of data at departmental or interdepartmental meetings.
• Maintain lab compliance by performing routine housekeeping, including keeping lab trackers up to date, support of analytical instrument maintenance, ordering and stocking of lab supplies, maintaining of reagents, sample management, and compliance to safety regulations.

• Bachelor’s degree in a scientific field. Some relevant experience in a development, a GxP environment, or with testing of proteins is preferable.
• Skills in Biological/Chemical Sciences, Math and English.
• Teamwork and communication are key attributes needed for this position, as this role will be part of a small team. A collaborative attitude and a positive work ethic are key traits for success.
• Excellent observation and attention to detail and accuracy for record keeping and documentation.
• Knowledge of GxPs.
• Excellent verbal and written communications skills.
• Able to work independently, and as part of a team on assigned projects.
• Proficiency with Microsoft Outlook, Word, Excel and PowerPoint software is required. Knowledge of statistics (i.e. Descriptive, ANOVA, DOE) is desirable.