Job Id
290966
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 Sr. Associate Scientist (QC Microbiology) is responsible for microbiology related analysis specifically including but not limited to in-process, drug substance, raw material and water sample analysis. Job duties include:

• Shift: Friday-Monday - 10pm to 8:30am.
• Conduct and lead a variety of analytical and microbiological tests on raw materials and products, ensuring quality compliance.
• Perform technical reviews of assays and assist in developing new methods and improving existing processes.
• Conduct analytical tests such as protein concentration analysis using UV/Solo VPE.
• Maintain suitable written records and document all work in accordance with cGMP and company procedures.
• Collaborate with internal departments to improve and execute processes within an ICHQ7 environment.
• Support investigations into out-of-specification (OOS) and out-of-trend (OOT) results and assist with root cause analysis.
• Communicate regularly with production and lab staff to provide feedback and support for quality-related services.

Who You Are

Minimum Qualifications:

• Bachelor’s degree in Biology, Chemistry, or other Life Science discipline.
• 1+ years of QC lab experience.

Preferred Qualifications:

• Current API knowledge.
• Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes.
• Knowledge and understanding of endotoxin (USP <85>) and Bioburden (USP<61>) testing
• Knowledge of analytical testing such as protein concentration analysis by UV/Solo VPE
• Experience with ICH Q7, 21CFR210, USP and EP.
• Experience writing technical documents and reports.
• Knowledge of aseptic technique and practices.
• Ability to perform minor troubleshooting on microbiological processes and associated laboratory equipment.
• Experience with documentation control: writes, reviews, and approves operating procedures, reports, protocols, and other QC controlled documents.
• Familiar with basic scientific/regulatory principles.
• Excellent written and verbal communication skills.
• Capacity to work independently.
• Ability to simultaneously manage multiple tasks/priorities good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.
• Strong problem-solving and time management skills.

• Shift: Friday-Monday - 10pm to 8:30am.
• Conduct and lead a variety of analytical and microbiological tests on raw materials and products, ensuring quality compliance.
• Perform technical reviews of assays and assist in developing new methods and improving existing processes.
• Conduct analytical tests such as protein concentration analysis using UV/Solo VPE.
• Maintain suitable written records and document all work in accordance with cGMP and company procedures.
• Collaborate with internal departments to improve and execute processes within an ICHQ7 environment.
• Support investigations into out-of-specification (OOS) and out-of-trend (OOT) results and assist with root cause analysis.
• Communicate regularly with production and lab staff to provide feedback and support for quality-related services