Senior Research Associate, Analytical Development

Job description

Our Analytical Development team is growing and we’re seeking a Senior Research Associate to participate in designing and executing experiments, as well as perform sample analysis utilizing HPLC, CE-SDS, iCIEF, and plate-based assays. These activities will support CMC, discovery, pre-clinical, and clinical development of existing and new lead candidates. This position will directly support the discovery of next-generation immune oncology drugs. It is a hands-on position that requires effective communication and documentation of results to enable the advancement of novel research molecules toward development of clinical candidates, which will ultimately lead to late-stage development and commercialization. Ideal applicants will be agile and highly driven, collaborative, team-oriented, possess excellent communication and organization skills, and carry a strong commitment to excellence. ### ESSENTIAL FUNCTIONS AND RESPONSIBILITIES - Perform HPLC and UPLC assays with minimal supervision including SEC and RP. - Execute CE-SDS and iCIEF analysis for novel protein therapeutics and contribute to method optimization, qualification, and lifecycle management. - Perform ELISAs for potency assessment. - Perform DLS/SLS analysis using an UNcle instrument and generate datasets that will be used for formulation development studies. - Perform subvisible particulate matter analysis by HIAC. - Perform formulation development studies and execute clinical in-use stability studies, transfer formulation knowledge internally. - Design, conduct, analyze, interpret, and report laboratory experiments; summarize results for meetings and regulatory filings. - Write and manage SOP’s and test methods. - Manage and maintain required reagents, laboratory environment, and equipment needed to carry out assignments. - Draft development reports, method qualification protocols, and method qualification reports - Prepare presentations for team meetings. - Work closely with team leaders to complete highest priority work to reach goals and milestones. - Other duties as assigned. ### REQUIRED SKILLS AND QUALIFICATIONS - Bachelor’s degree and 4-6 years of relevant industry experience or a master’s degree with 3-5 years of relevant industry experience. - Strong benchtop skills, experience with analysis of protein biologics and peptides. - Proficiency with HPLC and UPLC assays; at least 3 years of experience is required. SEC and RP are desired. - Experience with protein characterization techniques including CE-SDS, iCIEF, or related electrophoretic methods is preferred. - Experience performing ELISAs is desired but not necessary - Experience supporting analytical method qualification, comparability, stability, or formulation development studies is preferred. - Demonstrated ability to analyze complex datasets, identify trends, troubleshoot experiments, and communicate scientific conclusions effectively. - Ability to perform routine testing and to follow SOPs in a highly accurate and reproducible manner. - Desire and ability to learn new technologies and explore new approaches to innovate. - Training on project specific assays and ability to train others. - Proven experience with writing and maintaining SOPs. - Demonstrated ability to maintain accurate, complete, and contemporaneous experimental records in ELN systems in accordance with Good Documentation Practices (GDP). - Ability to work independently; anticipates and solves problems in a proactive fashion. - Must have excellent computer skills, and proficiency with Microsoft Excel and PowerPoint are required. - Good oral and written communication skills a must. - Excellent team player.