Job Title: QC Scientist II/III

Job Description

We are seeking a dedicated QC Scientist II/III to perform HPLC/UPLC testing on various samples including In-Process DS release, DP release, DS stability, DP stability, process validation, analytical method validation/transfer, method establishment/qualification, and other non-routine samples. This role involves conducting GMP testing in an analytical laboratory environment using HPLC and UPLC test methods, ensuring all activities meet EHS requirements, and maintaining high standards of laboratory safety and housekeeping.

Responsibilities

• Perform HPLC/UPLC testing on various samples including In-Process DS release, DP release, DS stability, DP stability, process validation, analytical method validation/transfer, and method establishment/qualification.
• Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods such as Reverse Phase, SEC, Titer concentration, and CEX.
• Accurately record and report analysis results in accordance with lab procedures and quality systems.
• Recognize and report out-of-specification/out-of-trend results to laboratory management, and recommend solutions.
• Maintain and troubleshoot analytical instrumentation and workspace as needed.
• Perform method validation and/or qualification testing as necessary.
• Author and/or review SOPs, test methods, forms, etc., in the document management system eDMS.
• Ensure compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Collaborate with internal and external customers to ensure clear and open communication is maintained when resolving and raising issues.
• Work with QC leads, PMs, and clients to maintain good health of client programs.

Essential Skills

• Minimum of 1 year of HPLC/UPLC experience in the quality/analytical/pharmaceutical industry or similar experience.
• Experience with a multitude of HPLC/UPLC assays is a plus, including SEC, CEX, Glycans, Peptide Map, etc.
• Knowledge of GMP regulations in a cGMP manufacturing environment.
• Working knowledge of scientific principles for a wide range of analytical techniques strongly preferred.

Additional Skills & Qualifications

• Prior use of EMPOWER is preferred but not required.
• Scientist II requires a minimum of 2 years of HPLC/UPLC experience in the quality/analytical/pharmaceutical industry or similar experience.
• Scientist III requires a minimum of 5 years of pharmaceutical HPLC/UPLC experience.

Work Environment

The work schedule is Monday-Friday from 8am-4:30pm, primarily involving bench work. This opportunity offers the potential to convert into a full-time position based on performance. You will be part of a team where your contributions are valued and you will have the opportunity for continual growth and learning in a culture that empowers your development.