Development Scientist I, Analytical Development & Clinical Quality Control – New Haven, CT

Development Scientist I, Analytical Development & Clinical Quality Control

Job Description

This is what you will do:

·       Perform characterization of biotherapeutics from research to commercial products.  The candidate should have an established history characterizing antibodies, proteins, and peptides by various analytical techniques; including running, developing, and troubleshooting. Assays include, but are not limited to: HPLC/UPLC, CE-SDS, icIEF, and fraction collection. 

·       The candidate should have good team, organizational, writing, and presentation skills.  In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Analytical Sciences, Process Development, Manufacturing, Quality Assurance and Quality Control groups.  The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to protein characterization, comparability, and CQAs is a crucial requirement of this position.

·       The candidate must be able to manage projects independently.  Additional responsibilities may include being a representative on cross-functional process development teams; and training and overseeing some day to day responsibilities of junior scientists.

You will be responsible for:

·       Leading and performing comparability and forced degradation studies.

·       Leading and performing protein variant (e.g., charge and size) enrichment, fractionation, and characterization.

·       Participate in cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts with the group.

·       Authoring CMC sections for regulatory, technical reports, department-specific protocols and reports, and general operating procedures. Leading the development and authoring of new procedures and work practices.

·       Lead innovative technology evaluation and independently developing protein characterization strategies.

·       Conduct experimental studies to develop and optimize analytical/characterization methods for biotherapeutic candidates.

You will need to have:

·       Familiar with investigating PTMs and other protein properties with analytical and characterization-based assays

·       Direct experience with analytical HPLC/UPLC, CE-SDS, icIEF, and fraction collection.

·       Good understanding and direct experience with protein characterization.

·       Understanding of comparability and forced degradation studies. Understanding of CQA assessments.

·       Ability to take initiative in problem solving and bring independent, scientific approach to method development. 

·       A thorough understanding of GLP and quality guidelines.

·       The individual must be able to give clear instructions and to train personal as required on practices within the laboratory. 

·       Planning and organizing skills are required to plan, execute, and track commitments of the laboratory and to adjust to changing priorities.

·       High emotional intelligence, excellent people skills, and effective communication skills.

·       The duties of this role are conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work c