Associate Scientist/Scientist - Analytical Development

Job Description

Job DescriptionDescription:

• 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.