Associate Scientist/Scientist - Analytical Development

Job Description Description:Perform routine and novel analytical testing to support biological therapeutic products from early-stage development through late-stage/commercialization.Lead the tech transfer to receive methods from research / GxP unit, development, qualification, and transfer of analytical methods to be used in research / GxP unit.Analytical methods may include, but not limited to: SE-HPLC, CEX-HPLC, HILIC-HPLC, reduced and nonreduced CE-SDS, icIEF, concentration by A280, and ELISA.Support Quality unit for GxP activities.Coordinate with other functional groups to support cell line development, formulation development, and upstream/downstream process development studies and have some understanding and experience with determining critical quality attributes of protein products.Participate in tech transfer, characterization, and comparability studies and analyze in-process and product-related impurities.Provide scientific input and demonstrate critical thinking into experimental design and execution.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, regulatory submission content, and give oral presentations of data at departmental or interdepartmental meetings.Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.Maintain lab compliance by performing routine housekeeping, including support of analytical instrument maintenance, ordering and stocking of lab supplies, maintaining of reagents, sample management, and compliance to safety regulations.Requirements:PhD with 3-years, Master's with 5-6 years, or Bachelor's degree in a scientific field with at least 8+ years of relevant experience in a development or GxP environment, especially with testing of proteins.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.