Senior Associate Quality Scientist

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

11d•$23 - $36•Onsite

About The Position

The Senior Associate Quality Scientist position will be responsible for safely performing operations that support our manufacturing departments as well as performing stability/Release testing (DS/DP) and other customer requests. The candidate will be expected to meet and exceed customer and regulatory body quality expectations for a current Good Manufacturing Practice (cGMP) facility, as well as understand how continuous improvements help us achieve our departmental goals by increasing efficiencies. The position is within the ADC Stability and Release team. It involves testing in accordance with GMP requirements in a laboratory environment, which is routinely audited by customers and regulatory agencies. The Senior Associate Quality Scientist may actively participate in audits and assist in resolving any audit findings. While this is currently a second shift position, there are times when a third shift work is necessary to support in process testing during manufacturing campaigns. Shift:-Friday-Tuesday 8am-4:30pm.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline.
3+ year of work experience in a lab setting and/or data review.

Nice To Haves

Experience with cGMP testing requirements and associated documentation.
Experience with wet chemistry, chromatography or microbiology(endotoxin)
Familiarity with general laboratory instrumentation and troubleshooting capabilities for when problems occur.
Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon.
Knowledge of safe chemical handling methods
Analytical capabilities, GDP and Data integrity and ALCOA.
Strong oral and written communication skills
Ability to accurately perform procedures independently.
Instrumental experience such as HPLC, GC, LCMS, UV, Solo VPE, CGE, and iCE is highly desirable.
Experience with Trackwise, Chromeleon, LIMS and SAP.
Antibody drug conjugate (ADC) experience.

Responsibilities

Perform (timely) analytical testing for the in-process samples and other activities.
Perform in-process microbiology (endotoxin) testing and data review.
Ensure quality through adherence to GMP requirements.
Verify training before performing tasks/assignments.
Contribute to support functions of the lab (e.g. maintain equipment, prepare reagents, restock lab supplies, waste disposal)
Communicate the status of operations and bring deviations to the attention of supervisor
Provide complete and accurate records consistent with quality guidelines and Good Documentation Practice (GDP) requirements.