Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in Woodbury, MN with locations in California, Minnesota, and the United Kingdom.
Kindeva partners with global pharmaceutical companies to commercialize products, with a particular focus on complex drugs and combination products. We are looking for a laboratory assistant to join our team.
Summary of Position
The person hired for the position of Quality Control Chemist will perform complex and routine analytical processes for the testing of Raw Materials, Hard Goods and Finished pharmaceutical products. The Quality Control Chemist will support issue resolution and communicate technical or other product quality issues. The QC Chemist is responsible for leading safety initiatives and training, while driving completion of new product and continuous improvement projects. This opportunity will require appropriate techniques and tools such as, Six Sigma, LEAN, and SPC, while demonstrating leadership in audits.
Job Responsibilities

• Ensure world-class safety within the quality control laboratory and Northridge Facility.
• Prepare sample solutions, standards, and reagents
• Perform wet chemical and instrumental analysis, including FTIR, HPLC, UV Spectrophotometer, Dissolution, Instron, Texture Analyzer and Gas Chromatography
• Analyze Packaging Materials, Raw Materials and Finished Products per USP/NF/EP Compendia and approved Test methods and Specifications
• Meet multiple testing cycle time requirements through scheduling, testing and documentation review
• Review and update lab documentation such as SOPs, worksheets, specifications and methods to reflect current processes, etc.
• Perform, support qualification, calibration and maintenance of quality control laboratory equipment
• Support resolution of non-conformances and investigations in the quality control laboratory
• Ensure timely completion of CAPA
• Identify, plan and complete continuous improvement projects within the laboratory and Northridge facility
• Support introduction of new analytical techniques and equipment to the quality control laboratory
• Ability to work flexible hours as needed to support production demands
• Work well in both team and individual environments
• Other duties as assigned

Requirements

• Bachelors degree or higher in a science discipline from an accredited university
• Basic understanding of GMP/GLP
• Minimum 1 years analytical testing experience

Preferred

• Bachelors degree or higher in Chemistry from an accredited university
• Testing experience within the pharmaceutical industry
• Familiar with Raw Material testing, Global compendia and ICH
• Familiar with Inhalation or Transdermal products and test methods
• Experienced in leading technical lab investigations
• Demonstrated strong oral and written communication skills
• Demonstrated ability to lead technical teams

Must be legally authorized to work in country of employment without sponsorship for employment visa status.