Senior Research Associate, Analytical Development

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.