Senior Research Associate, Analytical Development

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Develop and perform HPLC and UPLC assays with minimal supervision including SEC, HIC, IEX, and RP.
• Develop and perform iCIEF and CE-SDS assays.
• Develop and perform ELISAs.
• 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, train colleagues and facilitate method transfer to partners and CDMOs.
• 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 in related scientific discipline with 4-6 years of relevant industry experience or Master’s degree with 3-5 years of relevant industry experience required.
• Strong benchtop skills, experience with analysis of protein biologics and peptides.
• Proficient with the development of HPLC and UPLC assays; at least 3 years of experience is required. SEC, RP, HIC, and IEX experience is desired.
• Experience developing and performing ELISAs.
• Knowledge and familiarity in employing various analytical techniques, to include but not be limited to: CE-SDS, iCIEF.
• Experience with DLS/SLS (UNcle), HIAC, HIC and CE-SDS ELISA (Simple Western) blotting or similar technology preferred.
• Experience with formulation development with focus on antibodies or bispecifics is highly desired.
• Proven experience with writing and maintaining SOPs, ability to train others and to transfer methods to external partners.
• Ability to perform routine testing and to follow SOPs in a highly accurate and reproducible manner.
• Desire and ability to learn new technologies, thinking outside the box, and exploring new approaches to innovate.
• Training on project specific assays and ability to train others.
• Ability to work independently, anticipate, and solve problems in a proactive fashion.
• Excellent computer skills, proficiency with Microsoft Excel and PowerPoint required.
• Strong oral and written communication skills a must.