FLSA Status: Exempt Shift: M-F, 8a-5p Position Summary: The Chemistry Analyst III (Laboratory Lead) applies scientific principles, methods and techniques to troubleshoot chemical and instrumental analyzes, optimize current methods and processes, perform test methods and equipment validations, and identify/lead laboratory projects. The Lab Lead will work directly with the area supervisor to ensure timely release of product and facilitate the training of all laboratory analysts. Essential Duties & Responsibilities: •Coordination of day-to-day activities of laboratory analysts which include scheduling, sample prioritization, batch record review and release and other activities as required under the direction of the area supervisor. •Perform complex chemical and instrumental analyses to support laboratory functions such as in-process solutions, raw materials (API / Excipients), commodities, blended resin, film and final product solutions in multiple laboratories on an as needed basis. •Train new analysts in daily operations, documentation, instrumental & wet chemical methods (both theory and practice). •Support the area supervisor in the investigation of inconsistent results and possible root causes and solutions, including documentation of the investigation via applicable laboratory investigation / exception report documentation and the associated system. •Perform preventive maintenance (PM). Troubleshoot and resolve all instrument problems in the laboratory. •Work with vendors to evaluate instruments, and make decisions involving future instrument purchases based on needs and costs. •Assist with method development, method validation / transfer studies, and method remediation activities. •Set daily and weekly short-term goals to ensure timely release of product in conjunction with the area supervisor. •Adhere to cGMP's, SOP's and plant policies/guidelines. •May be cross-trained to work in other laboratory areas as dictated by the needs of the department. •Perform other related duties as assigned or required. Knowledge, Skills & Qualifications: •Must have successfully completed projects, demonstrating good communication, word processing and writing skills, and organizational and time management skills. •Must be able to provide general guidance to other analysts on a day-to-day basis. •Must follow organized thought processes and have the visual acuity to accurately complete the extensive necessary documentation, plus a thorough understanding of the chemistry and theory involved. •Must have technical writing capability and be familiar with validations and qualifications. •Capable of operating complex instrumentation with limited supervision. •Must be able to apply standard scientific principles, methods and techniques to trouble-shoot and resolve common analytical problems and technical service requests. •Must be able to resolve routine analytical and quality problems with minimal assistance. •Position requires an understanding and capability of performing maintenance on laboratory instrumentation on a daily and monthly basis. •Must be able to manipulate algebraic equations on a daily basis. •Must be able to use mathematics to solve routine problems. •Must be able to trouble-shoot and resolve a myriad of routine instrumental problems. •Must demonstrate good organizational and time management skills. •Must possess good communication and writing skills and be able to work effectively with all levels of individuals within the organization. •Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality. Education and Experience: * •Must be at least 18 years of age. •Bachelor’s Degree is required: Chemistry, Chemical Engineering, or Chemical Science (other science degrees will be considered) •At least 3-4 years recent analytical instrumentation experience is required; or a BS degree in Biology with 4 year’s recent analytical instrumentation experience. Thorough knowledge of the various instruments used in the lab, including: theory, preventive maintenance, troubleshooting and compendia terminology and requirements. *Physical Requirements and Work Environment: •Types of problems encountered: Individual will generate data that will be used as the criteria in the decision to continue or stop manufacture of solutions and filling process. •Must be able to work flexible schedules, including overtime, in response to work demand. •Office and laboratory environment. •Frequent exposure to hazardous chemicals, the numerous methodologies that are required to test product, and the time constraints under which the work is accomplished. •Must be able to lift 20 lbs unassisted. •Typically requires travel less than 5% of the time. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: Chemistry Analyst III (Laboratory Lead) Location: TX-Austin Requisition ID: 24300057