QC Scientist

Just is seeking a highly motivated 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. This individual will join the Quality Control group to provide in-process and drug substance sample testing in support of the GMP operations, laboratory staff training, GMP document authoring / revision and oversee initiatives to build infrastructure and processes for the new Commercial manufacturing facility in Redmond, WA. As a member of the QC team, the successful candidate will have GMP laboratory experience assessing biotherapeutics with UPLC and CE based test methods. Additional experience with method validation and ELISA based impurity or potency assays is a plus. The ideal candidate has a high attention to detail, is organized in their work, has strong written and verbal communication skills and works well independently and in teams.

Responsibilities:

• Perform QC analytical testing in support of the GMP manufacturing schedule and drug substance release by UPLC, CE and / or ELISA based methods
• Train laboratory staff in UPLC and CE based analytical methods, including method validation
• Compendial method qualification
• Write and revise Quality Control Methods, Standard Operating Procedures (SOPs), Materials Specifications, Drug Product Specifications and Drug Product Stability Protocols
• Work with team members to support the GMP QC Laboratory operations and build the infrastructure for the Commercial QC laboratory
• Partner with PD and external clients for the transfer and validation of analytical methods

Requirements:

• BS in Biochemistry, Chemistry or related field and 5 – 8 years of experience
• 5+ years of relevant experience in a cGMP QC laboratory or similar environment
• Proficient with Waters Empower, Sciex 32 Karat and Microsoft Office applications (Word, Excel)
• Experience with Waters HPLC, UPLC and Beckman PA800 CE systems
• Knowledge of GDPs, GMPs and DS / DP compendial assays (USP, EP, JP)
• Attention to detail and highly organized
• Technical writing including analytical methods, technical summary reports and Standard Operating Procedures
• Experience with a quality management system (QMS)

Preferred qualifications:

• Method validation experience
• Experience with ELISA based impurity or potency methods