Job Id
290785
St. Louis, Missouri, United States
Job Type
Full-time
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
At Millipore Sigma (CDMO) Cherokee, the Quality Scientist position will perform quality control activities in support of GMP products within the stability and release ADC (Antibody drug conjugates) team. The position will report to QC management.
- Shift: Friday - Monday 8pm- 6:30am (4x10).
- Perform data review for GMP testing and conduct timely analytical testing and related 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.
- Perform In-process testing of microbiology(endotoxin)
- Interface with customers and cross-functional departments.
- Train personnel and act as a technical consultant as needed and lead process improvement initiatives.
- Perform complex assays and processes requiring advanced skill and knowledge; design basic experiments, evaluate data, identify problems or limitations in the analysis, and draw conclusions.
- Contribute to support functions of the lab (eg. Maintain equipment’s, prepare reagents, restock lab supplies, and waste disposal).
Physical Attributes:
- Perform tasks while wearing personal protective equipment such as chemical protective clothing, goggles, respirator, gloves, etc.
- Lift, push, and or pull up to 40 pounds.
Who You Are
Minimum Qualifications:
- Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other Life Science discipline.
- 10+ years’ experience in analytical Chemistry.
OR
- Master’s Degree in Chemistry, Biochemistry, Biology, or other Life Science discipline.
- 5+ years’ experience in analytical Chemistry.
Preferred Qualifications:
- Antibody Drug Conjugate (ADC) testing experience.
- 5+ years of cGMP experience in pharmaceutical, biopharmaceutical or similar industry.
- Experience with ICE, Solo VPE, UV-Vis, KF, GC, LCMS, IC, CGE, and HPLC is highly desirable along with Chromeleon software.
- Strong technical writing and scientific reasoning.
- Experience with Trackwise, Chromeleon, LIMS and SAP.
- ELISA, Data Integrity, and ALCOA.
- Strong command of Microsoft excel word, smart sheets and power point.
- Experience in lean lab practices and continuous improvement initiatives.
- Strong technical writing, root cause analysis and scientific reasoning.
- Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon.
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