Senior Scientist, High Throughput Analytical Science

Just is seeking a motivated and creative Senior Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated scientist to join a fast-paced, collaborative, and multidisciplinary team. As a key member of the High Throughput Analytical group, you will possess strong skills in H/UPLC and CE method development and qualification, large molecule characterization, mentoring junior staff, and authoring regulatory authority correspondence and interaction. The successful candidate will possess strong leadership and management skills and a strong drive for laboratory work. Experience with comparability studies, liquid handling robotics, biosimilar development, as well as authoring regulatory documents is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

Responsibilities:

• Develop, qualify, and document analytical methods
• Work with team members to support process development teams with high-throughput analytical procedures
• Develop and implement molecule characterization strategies
• Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results
• Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods
• Represent Analytical Sciences in process teams
• Supervise and/or mentor associates

Requirements:

• BS + 10 years experience, MS + 5-7 years experience, or PhD with relevant post-doc experience in Chemistry, Biochemistry or related field
• Large molecule and protein characterization experience
• Strong assay development and qualification skills
• Strong background in H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF)
• Desire to work in a fast, collaborative, team-oriented environment

Preferred qualifications:

• Proven record with authoring regulatory documents (e.g. IND/BLA)
• Managerial experience
• Use of liquid-handling automation applications
• Experience with Biosimilar characterization and comparability
• Experience with troubleshooting complex instrumentation
• Direct interactions with FDA and other regulatory agencies a plus
• Characterization of complex glycoproteins
• Knowledge of mass spectrometry data
• Experience with compendial assays (USP, EP, JP)
• Strength in data science and informatics
• Experience with CMC and analytical team leadership