Chemist I

Kindeva Drug Delivery

ROLE SUMMARY

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. 

Ready to work with purpose? Look no further, we are hiring for a Chemist I to join our St. Louis Missouri team! 

Independently performs routine and non-routine quality control testing of raw materials, in process, finished product, and stability samples within the framework of site policies, departmental procedures, and current Good Manufacturing Practices (cGMP) regulations. Participates in and documents investigations, participates/coordinates team projects, and special project studies to accomplish company and departmental objectives. Records and reports data accurately and in compliance with current methods/Standard Operating Procedures (SOPs), United States Pharmacopeia (USP/NF), other compendia as applicable, and cGMP. Experienced in HPLC, GC, Chromatography Data Software application, titrations, pH, Karl Fisher, and General Wet Chemistry/Compendial Testing. Performs additional duties under the guidance of laboratory management or designee.

ROLE RESPONSIBILITIES

The essential functions of this position may include, but are not limited to:

• Performs routine set up, calibration, operation, and maintenance of laboratory test instruments/equipment.
• Analyzes samples per established departmental/site/corporate policies, specifications, and procedures.
• Prepares solutions and standardizes test solutions as defined in analytical method or compendia.
• Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements.
• Practices cGMP, which includes, but is not limited to, proper laboratory documentation and maintenance, archival of documentation/raw data, attention to specification limits for any tests performed, and immediate notification of any out-of-specification (OOS) results.
• Documents/records analytical tests/data, ensuring reports are accurate and complete with documentation of procedures, equipment/instruments, and reagents used in analytical testing.
• Demonstrates practical laboratory skills, and a thorough knowledge of chemistry theories, analytical techniques, and quality procedures.
• Reviews and revises SOPs, analytical methods and related procedures/documents, documentation of procedures, equipment/instruments, and reagents used in analytical testing.
• Performs other related duties as assigned.

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the minimum knowledge, skill, and/or ability necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: Bachelor Degree in Chemistry or related science field and a minimum of 3 years of experience, or an equivalent combination of education 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.

Computer Skills: To perform this job successfully, an individual should have knowledge of Windows based software applications such as Word, Excel, and Outlook; knowledge of chromatography data processing software, specifically Empower, is preferred/desirable.

The position requires regular onsite attendance.

Must have the ability to multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Must have the ability to work effectively under and manage to strict production, time, and performance deadlines. 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.

#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 
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