Associate Quality Scientist @ Merck

Job Information

Job Description:

Your Role:

Within the Life Sciences division of Millipore Sigma (CTDMO), the Associate Scientist (QC) position will perform quality control activities in support of GMP products at our Cherokee site. The position is within the Analytical Testing team. The job responsibilities include analytical testing and other activities in support of GMP manufacturing. The position will report to Rashad Alhachemi (QC Supervisor).

Responsibilities include:

• Safely perform operations to meet quality expectations
• Perform in-process, release and stability testing of antibody-drug conjugates & Bio-organics in accordance with applicable cGMP requirements
• Clean-up equipment and working areas during and after operations
• Ensure quality through adherence to cGMP requirements
• Promptly deliver data, adhering to Data Integrity & ALCOA+ principles for proper documentation
• Complete work required to achieve group/departmental goals and meet deadlines
• 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 GDP requirements
• Interface across department as needed
• Participate as needed in quality audits (FDA/Customer)
• Review and revise operating procedures (SOP) as needed
• Identify opportunities for process improvement
• Participate in process improvements under the guidance of a supervisor or scientist
• Take the necessary action to resolve any unsafe conditions
• Train personnel and act as a technical consultant as needed

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other life science discipline

OR

• Associate’s Degree in Chemistry, Biochemistry, Biology, or other life science discipline with 3+ years of experience working in a cGMP laboratory environment

Preferred Qualifications:

• General understanding of multiple techniques includes HPLC/UPLC, icIEF, Solo-VPE, CGE, SEC, ELISA, and LC-MS
• General understanding on Monoclonal antibodies (mAb) and antibody-drug conjugates
• Understanding on Chromeleon, SAP & LIMS

Company Information

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