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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), 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 Supervisor of ADC testing team.
Shift: Monday- Friday from 8 am to 5 pm.
Perform (timely) analytical testing and other 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 data review for GMP testing.
Ensure quality through adherence to GMP requirements.
Complete the volume of work required to achieve group/departmental goals and meet deadlines and communicate the status of operations and bring deviations to the attention of the supervisor.
Participate as needed in quality audits, provide complete and accurate records consistent with quality guidelines and GDP requirements.
Provide complete and accurate records consistent with quality guidelines and GDP requirements.
Interface with customers and cross-functional departments as needed.
Train personnel and act as a technical consultant as needed and lead process improvement initiatives.
Perform complex assays and processes requiring a higher level of skill and knowledge as well as identify problems and limitations of the analysis.
Perform advanced troubleshooting utilizing technical knowledge and theory.
Design basic experiments, evaluate data, and draw conclusions.
Provide logical explanations and potential solutions. Conduct training on complex analytical procedures.
Train and coach, the associates, and senior associates within the team.
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 or higher in life science discipline.
5+ years' experience in analytical chemistry.
Preferred Qualifications:
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.
Antibody Drug Conjugate (ADC) testing experience.
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.
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
