QC Chemist III

ROLE SUMMARY
The QC Chemist III independently performs routine and non routine raw material testing—including release, stability, and compendial verification—for both small molecule and biologic materials, with a primary focus on peptides and protein based therapeutics (e.g., monoclonal antibodies). The chemist ensures all testing complies with cGMP regulations, site quality policies, applicable compendia (USP/NF, EP), and internal procedures.
This role requires strong technical expertise in biochemical and analytical testing methods, critical thinking, excellent documentation practices, and the ability to support investigations, method verifications, method transfers, and departmental projects. The QC Chemist III is expected to work with a high degree of independence while also providing technical leadership and training to other team members.

Laboratory Testing & Instrumentation
• Perform and/or coordinate raw material release and stability testing using biochemical and analytical techniques, such as ELISA, SDS PAGE, Western Blot, protein concentration assays using plate reader, HPLC/UPLC, GC, Karl Fischer, pH, titrations, IR, and general wet chemistry.
• Execute compendial testing and method verifications for both small molecule and biologic raw materials, ensuring suitability and compliance.
• Conduct routine setup, calibration, operation, and preventive maintenance of laboratory equipment.
Data Integrity, Documentation & Compliance
• Record, analyze, and report results accurately and in accordance with cGMP, SOPs, and compendial requirements.
• Ensure timely peer review and archival of raw data, documentation, and electronic records.
• Immediately escalate out of specification (OOS) or atypical results, perform investigations, identify root causes and propose CAPAs.
Method Support & Continuous Improvement
• Perform method/compendial verifications and support analytical method transfers, including protocol drafting, execution, and reporting.
• Review and revise SOPs, analytical methods, and procedures to ensure clarity, compliance, and operational efficiency.
• Conduct periodic reviews of SOPs and identify opportunities for process optimization and drive improvements in testing workflows and lab systems.
Leadership & Collaboration
• Provide technical mentoring and training to laboratory staff on analytical methods, compendial procedures, equipment operation, and documentation practices.
• Coordinate testing schedules and priorities to ensure timely delivery of results in alignment with operational needs.
• Participate in cross functional initiatives, investigations, and special projects supporting departmental and organizational goals.
• Other duties, including weekend/off-shift work as assigned in support of laboratory and manufacturing operations.
Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific field with a minimum of 7 years of relevant experience; or
• Master’s degree in Biochemistry with minimum 5 years of relevant experience;
• An equivalent combination of education, training, and experience may be considered.
• Prior GMP laboratory experience is highly desirable, particularly supporting both large molecule (biologics such as proteins, peptides, mAbs) and small molecule pharmaceuticals in CDMO facility.
• Experience with compendial verification and method implementation in a regulated CDMO QC environment is strongly preferred.
• Hands on experience with biochemical assays (ELISA, SDS PAGE, Western Blot), protein characterization, and chromatography based techniques (HPLC/UPLC), GC, KF, IR, Titration, pH, wet chemistry methods etc.
• Proficiency with chromatography data systems (e.g., Empower, Chromeleon) and standard laboratory instrumentation.
• Strong understanding of cGMP, FDA/ICH regulations, laboratory safety, and data integrity expectations.
• Excellent analytical problem solving skills and scientific judgment.
• Strong written and verbal communication skills, including technical report writing.
• Ability to work independently, manage multiple priorities, and collaborate effectively in a fast paced environment.
• Commitment to quality, accuracy, compliance, and continuous improvement.
• Ability to perform basic statistical calculations and generate data graphs
• Be able to multi task across multiple responsibilities and manage competing priorities and cross functional collaboration.
• Ability to meet scheduled timelines in a dynamic CDMO environment


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