Job Id
290781
St. Louis, Missouri, United States
Job Type
Full-time
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role

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: Weekend -Friday to Monday – 12pm to 10.30 pm (4x10hrs).
• 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.

Physical Attributes:

• Additional needs may include the use of personal protective equipment such as a respirator or chemical protective clothing for extended periods of time.

• Occasional lifting and pushing up to 40 pounds.

  Who you are:

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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

• Shift: Weekend -Friday to Monday – 12pm to 10.30 pm (4x10hrs).
• 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