The Scientist position will be a member of the Analytical Development (AD), responsible for in-process, bulk drug substance and drug product testing for manufacturing support and release and characterization of Agenus antibody products.
AD supports the life cycle of Agenus pipeline products, developing and optimizing existing or novel analytical methodologies to establish robust assays that can be used to characterize product and its components throughout the various stages of the development cycle. The methods will then be slated for transfer to Quality Control and external contract organizations where they will be fully validated for use in late phase product testing.
This individual will work to ensure the appropriate and timely progression of methods development through qualification. This individual will also be expected to perform methods under a cGMP and GLP regulated environment and comply with Agenus Quality Systems.
The candidate must have in depth scientific knowledge and hands-on experience in order to lead or guide the development, robustness testing, risk assessment, and support methods transfer and validation of analytical methods, (Spectrophotometry, wet-chemistry, ELISA and PCR a plus). Experience with all phases of antibody drug development to commercial product support is highly desirable. This individual is also expected to represent Analytical Development as a member of internal and external cross functional project teams.
Excellent communication, technical writing and presentation skills are essential. Prior leadership or project management experience is very useful. Proficiency with Microsoft Word, Excel and PowerPoint software is required. Knowledge of statistics (i.e. ANOVA, DOE) is desirable.
• Meet corporate objectives for the development and qualification/validation of assays such as: HPLC, Spectrophotometric and ELISA assays to test and characterize proteins and peptides of interest.
• Perform routine assays to support pharmaceutical products lifecycle, such as development samples from Purification, Formulation, Manufacturing and Pre-clinical departments.
• Troubleshoot methods, compile, review and submit accurate reports.
• Provide technical expertise guidance to address QC deviations and troubleshooting.
• Provide technical expertise guidance to antibody product characterization and comparability.
• Support the testing of samples for lot release and stability under GLP/cGMP guidelines as needed.
• Provide scientific input and demonstrate critical thinking into experimental design and execution.
• Compile and summarize test data and perform data analysis
• Write technical development reports and give oral presentations of data at departmental or interdepartmental meetings.
• Coordinate with other functional groups to support upstream and downstream, process development studies to meet corporate objectives.
• Write, review and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures.
• Oversee analytical instrument maintenance, calibration and trouble-shooting.
• Responsible for maintaining and ensuring adherence to GLP/cGMP compliance and Agenus Quality Systems
• Author or contribute to analytical sections for IND and BLA submissions
• Understanding of ICH guidelines such as “Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products”
• Understanding/Experience with determining critical quality attributes of product (post translational modifications, aggregation, glycosylation)
• Bachelors degree with a minimum of 8 years experience or graduate (MS or PhD) degree in Biochemistry, Chemistry or related scientific field with 6+ years of relevant experience, with experience working in a GLP/GMP environment or QC experience.
• Able to multi-task in a fast pace environment.
• Able to work independently and as part of a team to accomplish work activities and achieve goals.
• Excellent organizational and record-keeping skills.
• Effective communication skills.
• Detail oriented.
• Able to work effectively alone and in teams
• Able to prioritize and demonstrate flexibility in schedule as demanded by project needs or management.