Sr. QC Analyst (Biosimilar)
The Sr. QC Analyst will support product testing (release, stability, and in-process samples) for both clinical and commercial activities within the Quality Control environment. Author phase appropriate protocols and reports for transfer and validation of test methods including execution and establishment of test methods within Quality Control. Review laboratory documentation for accuracy, participate with the team to meet group goals and perform routine laboratory duties. Author quality records such as laboratory investigations, deviations and CAPAs. Participate in the preparation of investigations, summaries and reports as needed. This position is dedicated to support the Biosimilar project.
- Perform routine and non-routine release, stability, and in-process sample testing and documentation under cGMP.
- Perform method transfer of test methods from development to Quality Control including authoring of protocols and reports.
- Conduct phase-appropriate method validation including authoring of protocols and reports.
- Establish test methods for analysis of the Biosimilar product including defining preparation, qualification, and requalification requirements for critical reagents and reference standards.
- Review laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents
- Author quality records such as laboratory investigations, deviations, CAPAs and change controls, including leading thorough and timely investigation and/or implementation activities.
- Maintain laboratory space to regulatory expectations and internal procedures on a regular basis
- Provide training to laboratory analysts, as needed.
- Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.
- Requires a Bachelor of Science in Biochemistry, Biology or a related pharmaceutical-biotechnology discipline. Master of Science in related field is highly desired.
- A minimum 5 years work experience within a GMP environment working with peptides and proteins.
- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC/UPLC chromatography, including Waters Empower software is required.
- Solid experience in the development, optimization and validation of analytical techniques is highly desirable.
- Solid technical training and troubleshooting experiences are essential.
- Experience in performing data audit trail review and a strong understanding of data integrity principles within a GMP environment.
Knowledge, Skills and Abilities
- Knowledge of cGMP requirements and ICH guidelines.
- Excellent interpersonal and communication skills in a team-oriented environment are required.
- Strong critical thinking and problem-solving skills.
- Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.
- Proficient written and verbal communication skills are required.
- Proficient in the use of Microsoft Word and Excel
- Experience with statistical software such as JMP