QC Chemist III

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the world. Why KindevaPurpose-driven work environmentSignificant growth potentialCollaborative team cultureDirect impact on patient careIndustry-leading innovationThe 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 will serve as a technical resource within the laboratory supporting finished product release stability testing and raw material testing while helping drive continuous improvement 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 role supports QC testing of Finished Material Release and Stability testing within the QC Chemistry laboratory to support multiple manufacturing :Perform and coordinate routine setup calibration operation and maintenance of laboratory instruments and samples using a variety of analytical techniques and instrumentation in accordance with established procedures and or coordinate testing schedules to support business priorities and timely completion of laboratory and standardize solutions as defined by analytical methods and applicable assigned work safely and in compliance with regulatory company and compendial with or coordinate routine verification of laboratory standards solutions and cGMP principles including proper documentation data archival peer review and immediate notification of out-of-specification (OOS) analytical reports and ensure documentation is accurate complete and advanced knowledge of chemistry theories analytical techniques compendia requirements and laboratory quality and revise SOPs analytical methods and related documentation while recommending improvements to testing compendial verifications and support method validations for new product technical transfers including protocol writing execution and and coordinate training activities to qualify colleagues on additional methods procedures and compendial :Knowledge of USP EP and other applicable compendia cGMP guidelines FDA regulations laboratory safety procedures SDS requirements and laboratory understanding of inorganic and organic chemistry principles including both large and small molecule pharmaceutical degree in Chemistry Biochemistry or a related science field with a minimum of 7 years of experience or a Masters degree in Biochemistry with 35 years of experience or an equivalent combination of education and experience in a GMP-regulated environment is highly desirable particularly with both large and small molecule pharmaceuticals and technical transfer to read and interpret compendial methods SOPs technical procedures professional journals and governmental regulations and to author scientific and technical to perform basic mathematical and statistical functions and graph problem-solving skills with the ability to collect data establish facts and draw valid with Microsoft Office applications including Word Excel and Outlook. Experience with chromatography data systems particularly Empower is 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 to manage multiple priorities and work effectively under strict production and performance to work beyond a typical work schedule including occasional weekends and holidays as business needs Demands/Qualifications:Employee is required to regularly use hands in order to handle materials and suppliesEmployee is required to use computers for an extended period each dayEmployee is required to effectively use electronic communicationEmployee is required to regularly stand and walk for extended periods of timeEmployee must occasionally lift and/or move up to 20 poundsAbility to use proper PPE and be conscious of the work area hazardsEmployee is required to follow all site safety proceduresJoin our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.# LI-Onsite