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 c

GMP, 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 California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!