QC Chemist III

21h21 hours ago

Kindeva Drug Delivery

Bridgeton, US · Full-time · $85,000 – $115,000

About this role

The QC Chemist III independently performs routine and non-routine raw material testing—including release, stability, and compendial verification—for small molecule and biologic materials, with primary focus on peptides and protein-based therapeutics like monoclonal antibodies. Ensures all testing complies with cGMP regulations, site quality policies, USP/NF, EP, and internal procedures. Requires strong technical expertise in biochemical and analytical testing methods, critical thinking, and excellent documentation practices.

Daily responsibilities include performing biochemical and analytical techniques such as ELISA, SDS-PAGE, Western Blot, protein concentration assays, HPLC/UPLC, GC, Karl Fischer, pH, titrations, IR, and wet chemistry. Coordinates raw material release and stability testing, executes compendial verifications, and conducts routine equipment setup, calibration, operation, and preventive maintenance. Records, analyzes, and reports results accurately per cGMP, SOPs, and compendial requirements, escalating OOS or atypical results promptly.

Works with high independence while providing technical leadership, mentoring laboratory staff on methods, procedures, equipment, and documentation. Coordinates testing schedules to meet operational needs and participates in cross-functional initiatives, investigations, and projects. Supports manufacturing operations, including weekend/off-shift work as assigned.

Supports method verifications, analytical method transfers, protocol drafting, execution, and reporting. Reviews and revises SOPs, analytical methods, and procedures for clarity, compliance, and efficiency. Identifies opportunities for process optimization in testing workflows and lab systems.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, or related scientific field with minimum 7 years relevant experience; or Master’s degree in Biochemistry with minimum 5 years relevant experience
Prior GMP laboratory experience supporting large molecule (biologics such as proteins, peptides, mAbs) and small molecule pharmaceuticals in CDMO facility
Experience with compendial verification and method implementation in regulated CDMO QC environment
Hands-on experience with biochemical assays (ELISA, SDS-PAGE, Western Blot), protein characterization, and chromatography (HPLC/UPLC), GC, KF, IR, titration, pH, wet chemistry
Proficiency with chromatography data systems (e.g., Empower, Chromeleon) and standard laboratory instrumentation
Strong understanding of cGMP, FDA regulations

Responsibilities

Perform and/or coordinate raw material release and stability testing using biochemical and analytical techniques such as ELISA, SDS-PAGE, Western Blot, HPLC/UPLC, GC, Karl Fischer, pH, titrations, IR, and wet chemistry
Execute compendial testing and method verifications for small molecule and biologic raw materials
Conduct routine setup, calibration, operation, and preventive maintenance of laboratory equipment
Record, analyze, and report results accurately in accordance with cGMP, SOPs, and compendial requirements
Escalate out-of-specification (OOS) or atypical results, perform investigations, identify root causes, and propose CAPAs
Perform method verifications and support analytical method transfers, including protocol drafting, execution, and reporting
Provide technical mentoring and training to laboratory staff on analytical methods, compendial procedures, and equipment operation
Coordinate testing schedules and participate in cross-functional initiatives and special projects