QC Chemist III

The Impact You Will Make Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. As a Chemist III, you will play a key role in ensuring the quality, safety, and reliability of pharmaceutical products that impact patients worldwide. Working within a fast‑paced cGMP laboratory environment, you will independently perform routine and non‑routine quality control testing, method validations, and technical transfers for both small and large molecule products. You will serve as a technical resource within the laboratory, supporting finished product release, stability testing, and raw material testing while helping drive continuous improvement initiatives. In addition to performing complex analytical testing, you will coordinate testing activities, support technical transfers, train colleagues, and contribute to investigation and validation activities that keep our operations inspection‑ready and compliant. This role supports QC testing of Finished Material, Release, and Stability testing within the QC Chemistry laboratory to support multiple manufacturing facilities. Responsibilities Perform and coordinate routine setup, calibration, operation, and maintenance of laboratory instruments and equipment. Analyze samples using a variety of analytical techniques and instrumentation in accordance with established procedures and specifications. Lead or coordinate testing schedules to support business priorities and timely completion of laboratory activities. Prepare and standardize solutions as defined by analytical methods and applicable compendia. Perform assigned work safely and in compliance with regulatory, company, and compendial requirements. Assist with or coordinate routine verification of laboratory standards, solutions, and documentation. Practice cGMP principles, including proper documentation, data archival, peer review, and immediate notification of out‑of‑specification (OOS) results. Compile analytical reports and ensure documentation is accurate, complete, and compliant. Demonstrate advanced knowledge of chemistry theories, analytical techniques, compendia requirements, and laboratory quality systems. Review and revise SOPs, analytical methods, and related documentation while recommending improvements to testing procedures. Perform compendial verifications and support method validations for new product technical transfers, including protocol writing, execution, and reporting. Lead and coordinate training activities to qualify colleagues on additional methods, procedures, and compendial testing. Qualifications Knowledge of USP, EP, and other applicable compendia, cGMP guidelines, FDA regulations, laboratory safety procedures, SDS requirements, and laboratory instrumentation. Strong understanding of inorganic and organic chemistry principles, including both large and small molecule pharmaceutical products. Bachelor's degree in Chemistry, Biochemistry, or a related science field with a minimum of 7 years of experience, or a Master's degree in Biochemistry with 3–5 years of experience, or an equivalent combination of education and experience. Laboratory experience in a GMP-regulated environment is highly desirable, particularly with both large and small molecule pharmaceuticals and technical transfer activities. Ability to read and interpret compendial methods, SOPs, technical procedures, professional journals, and governmental regulations, and to author scientific and technical documentation. Ability to perform basic mathematical and statistical functions and graph data. Strong problem‑solving skills with the ability to collect data, establish facts, and draw valid conclusions. Proficiency with Microsoft Office applications, including Word, Excel, and Outlook. Experience with chromatography data systems, particularly Empower, is preferred. Experience with biochemistry and analytical techniques including ELISA, SDS‑PAGE, Western Blot, Protein Concentration, HPLC, GC, chromatography data software, titrations, pH, Karl Fischer, and general wet chemistry/compendial testing. Ability to manage multiple priorities and work effectively under strict production and performance deadlines. Willingness to work beyond a typical work schedule, including occasional weekends and holidays as business needs require. Physical Demands/Qualifications Employee is required to regularly use hands in order to handle materials and supplies. Employee is required to use computers for an extended period each day. Employee is required to effectively use electronic communication. Employee is required to regularly stand and walk for extended periods of time. Employee must occasionally lift and/or move up to 20 pounds. Ability to use proper PPE and be conscious of the work area hazards. Employee is required to follow all site safety procedures. California residents should review our Notice for California Employees and Applicants before applying. 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. #J-18808-Ljbffr