QC Associate Scientist, Chemistry

Just is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a motivated individual to join a fast-paced, collaborative, and multidisciplinary team to provide QC analysis of in-process, drug substance, and drug product samples in support of our GMP operations. The successful candidate will have some experience in analytical separations and compendial methods for protein therapeutics. The ideal candidate has a high attention to detail, is organized in their work and works well independently and in teams.

Responsibilities:

• Perform QC chemistry release testing in support of the GMP manufacturing of drug substance and drug product
• Work with team members to support the GMP QC Laboratory operations including large molecule stability study testing by UPLC, CE, icIEF, and compendial methods
• Assure timely completion of GMP documentation and adherence to good documentation practices.
• Write and revise Quality Control Methods, and Standard Operating Procedures (SOPs)
• Maintain, procure and on-board new GMP laboratory equipment
• Work cross-functionally ensuring successful method transfer, qualification, and method validation

Requirements:

• Relevant experience with HPLC / UPLC chromatography and/or capillary electrophoresis techniques
• BS/BA in Chemistry, Biochemistry, or related field

• High attention to detail and organized
• Experience with Microsoft Office apps (Word, Excel, PowerPoint)

Preferred qualifications:

• Experience in a cGMP environment
• Familiarity with capillary electrophoresis or chromatography data systems