What are the responsibilities and job description for the Chemist II position at Kindeva Drug Delivery?
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
In this role, you will be responsible for accurately recording and reporting data in full compliance with current methods, Standard Operating Procedures (SOPs), United States Pharmacopeia (USP/NF), relevant compendia, and cGMP regulations. You will leverage your expertise in high-performance liquid chromatography (HPLC), gas chromatography (GC), Chromatography Data Software applications, titrations, pH measurement, Karl Fischer analysis, and general wet chemistry/compendial testing to ensure precise and reliable analytical results. Your attention to detail and commitment to regulatory excellence will be critical in maintaining quality and compliance within the laboratory environment.
Role Responsibilities
o Performs/coordinates routine set up, calibration, operation, and maintenance of laboratory test instruments/equipment as needed.
o Analyzes samples using various techniques/instrumentation per established departmental/site/corporate policies/compendial pharmacopoeia specifications, and procedures.
o Prepares solutions and standardizes test solutions as defined in analytical method or compendia.
o Practices cGMP, which includes, but is not limited to, proper laboratory documentation and maintenance, archival of documentation/raw data, peer review, attention to specification limits for any tests performed, and immediate notification of any out-of-specification (OOS) results.
o Compiles reports/documentation of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment/instruments, and reagents used in analytical testing.
o Reviews and revises SOPs, analytical methods and related procedures/documents. May recommend clarification or request optimization of test methods/procedures for consistent/compliant processes.
o Lead/coordinate training of colleagues for qualification on additional test methods/procedures.
Basic Qualifications
Knowledge of compendia; USP, EP, and others as applicable, cGMP guidelines, FDA regulations; laboratory safety procedures, laboratory instrumentation, and SDS; knowledge of inorganic and organic chemistry principals.
Education/Experience:
Bachelor Degree in Chemistry or related science field and a minimum of 3 years of experience, or an equivalent combination of educations and experience/training; some laboratory experience in a GMP regulated environment is highly desirable.
Language Ability: Ability to read and understand applicable compendia methods, SOPs, general business periodicals, professional journals, technical procedures, and or governmental regulations; author scientific/technical reports, business correspondence and departmental procedures.
Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals; perform simple statistical functions and graph data.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.
Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
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