Associate Quality Scientist- 2nd shift

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

9d•$23 - $37•Onsite

About The Position

As an Associate Quality Scientist on our ADC Stability and Release team, you will safely execute cGMP-compliant analytical testing for drug substance and drug product (DS/DP) release, stability, and specialized customer requests. Reporting to the Second Shift QC Supervisor, this role works 2:00 PM – 10:30 PM in a routinely audited, high-standard laboratory environment. You will actively support regulatory and customer audits, resolve findings, and contribute to continuous improvement initiatives that boost departmental efficiency and exceed quality standards.

Requirements

Bachelor’s degree in chemistry, biochemistry, biology or other life science discipline OR Associate degree in chemistry, biochemistry, biology, or other life science discipline with 3+ years of analytical testing experience in a cGMP laboratory environment

Nice To Haves

Experience with antibody-drug conjugates (ADCs) and safe chemical handling protocols
Proficiency with lab software and enterprise systems (TrackWise, Chromeleon, LIMS, and SAP)
Strong working knowledge of general laboratory instrumentation, including the ability to troubleshoot equipment and technical assay issues
Deep understanding of ALCOA principles, Good Documentation Practices (GDP), and data integrity standards
Ability to work independently with high accuracy, as well as adapt flexibly within a dynamic team environment
Strong written and verbal communication skills

Responsibilities

Perform timely analytical testing and other activities to support cGMP release, in-process and stability testing of drug substances and drug products
Provide complete and accurate records consistent with quality guidelines and good documentation practice (GDP) requirements
Ensure quality through adherence to GMP requirements
Complete the volume of work required to achieve group/departmental goals, meet deadlines, communicate the status of operations and bring deviations to the attention of the supervisor
Provide complete and accurate records consistent with quality guidelines and GDP requirements
Perform complex assays and processes requiring a higher level of skill and knowledge and identify problems and limitations of the analysis
Perform advanced troubleshooting utilizing technical knowledge and theory
Design basic experiments, evaluate data, and provide logical conclusions and solutions
Contribute to support functions of the lab (e.g. maintain equipment, prepare reagents, restock lab supplies, and waste disposal)