Senior Scientist, Protein Mass Spectrometry

The role:

We are seeking a Senior Scientist with expertise in Protein Mass Spectrometry (MS) to join our Analytical Development team as a subject matter expert in mass spectrometric analysis of protein therapeutics with the goal to understand structural/biological function correlation to support the Agenus therapeutic protein pipeline (monoclonal antibodies, fusion proteins, bispecific antibodies, etc.).

This role will report to the head of Analytical Development and will be responsible for developing, qualifying, and performing Liquid Chromatography-Mass Spectrometry (LC-MS) based methods to be used for characterization and/or GMP quality control of therapeutic proteins in all clinical stages (from early to pre-BLA). The candidate will design and execute scientific studies and will collaborate extensively with cross-functional Agenus staff and with representatives from contract manufacturing and testing organizations.

In the role you will:

· Establish (develop, optimize and qualify) and perform LC-MS based analysis to characterize product and process variants for Agenus protein therapeutic candidates including analyses of intact/reduced molar mass, post-translational modifications (oxidation, deamidation, glycosylation, etc.), disulfide bond structure, free thiols, sequence variant analysis, etc. This also includes routine maintenance and training of group members, as well as knowledge sharing with MS groups located in other internal sites.

· Support pharmaceutical products throughout their lifecycle, such as development samples from Upstream Process Development and Downstream Purification Development, Formulation Development, DS and DP Manufacturing.

· Provide scientific input and demonstrate critical thinking into experimental design and execution

· Write technical development reports and give oral presentations of data at departmental or interdepartmental meetings.

· Write, review, and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures.

· Act as analytical subject matter expert and contribute to the authoring and review of regulatory CMC sections (IND, BLA/MAA).

· 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.

· Perform a variety of analytical testing (HPLC, CE based etc.) as needed to support various stages of projects.

· Coordinate with other functional groups to support upstream and downstream process development studies and support critical quality attributes assessment efforts.

Qualifications: About you

· PhD with 4 years+ of relevant experience, Master with 6 years+ of relevant experience, or Bachelor’s degree in a scientific field with at least 8 years of relevant industrial protein mass spectrometry experience in the protein therapeutics area. PhD with 4 years+ postdoctoral experience is also acceptable for individuals with demonstrated scientific achievements in protein mass spectrometry.

· Demonstrated expertise in the application of protein mass spectrometry in structural elucidation of mAb related protein therapeutics using LC-MS (e.g., Thermo Orbitrap). Familiar with mAb structure/common modifications; and proficient in using MS database software (e.g., Biopharma Finder) to aid data analysis.

· Working knowledge of separation science (liquid chromatography and capillary electrophoresis)

· 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, attention-to-detail, accuracy for record keeping, and documentation.

· Excellent verbal and written communications skills.

· Ability to work independently, and as part of a team on assigned projects.

· Proficiency with Microsoft Word, Excel and PowerPoint software is required.

· Knowledge of statistics (i.e. Descriptive, ANOVA, DOE) is desirable.

· Knowledge of cGMPs; Understanding of ICH guidelines such as “Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products” and QbD principles described in Q8(R2) Pharmaceutical Development.

· Experience with separation technologies such as HPLC (SEC, IEC, RP, HIC, etc.), CE-SDS, and spectrophotometry to test and characterize proteins and related compounds (e.g., impurities, post-translational modifications).

· Experience in the design, development, and qualification/validation of analytical methods and product characterization for monoclonal antibody therapeutics is strongly preferred.

· Have some understanding and experience with determining critical quality attributes of protein therapeutics.

· Prior experience supporting process development studies is preferred

· Learning Agility: Capability to think through problems from a fresh point of view, curiosity and passion for ideas and solving puzzles, and love of learning.

· Detail Orientation: Ability to organize and prioritize many different important tasks.

· High Execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, ownership, and a strong drive to achieve goals.

· Collaboration: Demonstrated ability to work cross-functionally, manage crises and align interests of multiple parties, and aptitude for mastering operational specifics of multiple programs.

· Communication: Excellent written and oral communication skills, technical writing and presentation skills are essential.

· Flexibility: Ability to adapt to changes, assess priorities, and remain focused on goals.

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The targeted salary range for this position is 120,000-147,500 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.