Senior Scientist, High Throughput Analytical  

Location
Redmond, WA
Posted
Dec 03, 2021
Ref
REQ-03723
Hotbed
BioForest
Required Education
Masters Degree/MBA
Position Type
Full time

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. The new scientist will join a fast-paced, collaborative, and multidisciplinary team and will be responsible for developing and executing separations methods for support of process development, cell line development, and release testing of biotherapeutics. 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 in process teams
•Supervise and mentor associates

Requirements:
•BS + 10 years experience, MS + 5-7 years experience, or PhD + 2 years experience in Chemistry, Biochemistry, or related field
•Strong background in H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF)
•Large molecule and protein characterization experience
•Strong assay development and qualification skills Desire to work in a fast, collaborative, team-oriented environment

Preferred qualifications:
•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
•Knowledge of mass spectrometry methods
•Characterization of complex Glycoproteins
•Experience with compendial assays (USP, EP, JP)
•Strength in data science and informatics
•Experience authoring regulatory documents (e.g. IND/BLA) a plus
•Experience with CMC and analytical team leadership

Worker