Associate Quality Scientist

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 Associate Quality Scientist position (QC Stability) will be responsible for stability studies (launch/pull/data compilations) performed in Cherokee QC laboratory. The candidate will be expected to meet and exceed customer and regulatory body quality expectations for a Good Manufacturing Practice (GMP) facility, as well as understand how continuous improvements help us achieve our departmental goals by increasing efficiencies. The Associate Quality Scientist may actively participate in audits and assist in resolving any audit findings. This position will report to Senior Supervisor of Stability and lab services.

• Ensure quality through adherence to GMP requirements. Verify training before performing tasks/assignments.
• Complete the volume of work required to achieve group/departmental goals and meet deadlines.
• Draft, review and approve stability protocol as per ICH guidelines and SOP.
• Generate stability associated paperwork stability launch/pull.
• Complete and document the stability pull.
• Submit the sample to the laboratory.
• Prepare interim reports with assay results.
• Drafting stability summary report (SSR) and identify any out of trend or atypical results and escalate to the supervisor.
• Archive and store the data.
• Provide complete and accurate records consistent with quality guidelines and GDP requirements. 
• Provide logical explanations and potential solutions.
• Tracking the data from QC testing and review team to meet on time deliverables (OTD)
• Investigate late stability deviations, stability excursions with the stability chambers.
• Occasionally interact with customers and updating the stability program status and addressing stability program related queries.

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 may be required.

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biochemistry, Biology, Chemical Engineering or other life science. 
• 1+ year of work experience in a lab setting.

Preferred Qualifications:

• Stability guideline ICH Q1A.
• 1+ years of previous laboratory experience is desired in a cGMP environment.
• Strong time management, verbal and written communication skills.
• General laboratory safety and practices.
• Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211 and/or ICH Q7A).
• Basic knowledge of Microsoft Word, Excel, Smart sheets, LIMS and SAP.
• Experience on Solo VPE, HPLC, UV, and Proteins.
• Antibody Drug Conjugate (ADC) product experience.
• Experience in lean lab practices and continuous improvement initiatives.
• Strong technical writing, root cause analysis and scientific reasoning.

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html