Chemist

Summary

The Quality Controls Laboratory group conducts routine testing for manufactured products. Perform chemistry laboratory procedures in compliance with specifications in Standard Operating Procedures (SOPs) and Standard Test Procedures (STPs) used to support testing and product release. Skills of interest include chemistry assay validation/troubleshooting, training, project management, and report writing.

• Support daily decision-making by preparing data analysis and recommendations; elevate risks per SOP
• Execute and troubleshoot routine assays; document deviations and contribute to investigations
• Draft SOPs and implement defined improvements; participate in LEAN events
• Perform basic statistical analysis and generate routine reports
• Interact with interdepartmental customers (Manufacturing, Regulatory, Quality Assurance)
• Perform laboratory testing associated with transfer projects
• Work with Maintenance and Engineering to improve laboratory and equipment operation
• Participate in outline reviews as an SME; provide SAP data extracts and perform routine data analytics
• Support routine laboratory activities outside of testing (LEAN projects, Critical Reagent Management)
• Participate in laboratory responsibilities including training and paperwork review/approval and investigation support
• Adhere to testing schedules to accomplish high-volume critical work without compromising result integrity
• Communicate effectively with colleagues to meet timelines

• B.S. or M.S. (or equivalent) in Chemistry or Biochemistry
• M.S. with 2–6 years chemistry laboratory experience, or B.S. with 4–8 years
• Experience performing/troubleshooting/developing chemistry assays
• Exceptional organizational, communication, and interpersonal skills

• Strong analytical skills using chemistry instruments/techniques including HPLC, PA800, Maurice, Biomek i5, GC, AA, UV/Vis
• Proficient in Empower
• Microsoft Word and PowerPoint; advanced Microsoft Excel for data analysis

• Understanding of biological and chemical processes common to Quality Control testing
• Understanding of chemical regulatory requirements and licensure process
• Self-starter; prioritize work and work efficiently with minimal supervision
• Complete calculations using basic math; understand metric system and basic statistics
• Solve practical problems with concrete variables; make logical decisions
• Ability to make laboratory decisions in absence of supervision
• Recognize product quality issues based on company guidelines
• Train colleagues in fundamental and technical aspects of chemistry assays
• Excellent verbal/written communication, organizational and interpersonal skills

• Advanced understanding of chemistry and biochemistry
• Experience with facility start-up and analytical method transfer
• Experience with equipment qualification
• Existing knowledge of FDA, USDA, EMA, and compendial requirements for Quality Control assay development/testing
• Proven project/time management and technical writing of protocols and reports

• Manual dexterity; sitting or standing at laboratory bench/desk
• Close vision work
• Occasional need to sit/reach with hands and arms
• Ability to work flexible hours, weekends, and overtime