Scientist, Clinical Qc Jobs

Position: Scientist, Clinical QC

Location: Warren, NJ

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

Position Summary

This role is responsible for supporting Quality Control bioanalytical testing for release of clinical and development products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, this position will be able to assist with training and assay transfers. Primary role will revolve around performing data review, review of PAV protocols and reports. This role will also provide support for the molecular team from the SME perspective when the Manager is on leave or as needed.

Key Responsibilities

• Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.
• Performs other tasks as required.
• Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.
• Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Help manage method co-qualification/transfer and analyst training.
• Be responsible for cGMP compliance in all aspects of laboratory operations.
• Help manage reagent and control qualification
• Participate in site team supporting and managing regulatory inspections and findings.
• Serves as primary POC and Subject Matter Expert for QC Molecular Assays and Laboratory functions
• Own and evaluate relevant change controls, investigations, deviations, OOS and CAPAs.

Qualifications & Experience

• Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment.
• Ability to interpret and author general, technical, and complex technical and quality documents.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Advanced organizational and time management skills.
• Experience in assay transfer is preferred
• Advanced knowledge and implementation of data integrity principles.
• Advanced teamwork and facilitation skills. Ability to collaborate cross functionally to drive operational and quality excellence.
• Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.
• Advanced verbal and written communication skills.
• Proficiency in MS Office applications.
• Minimum of 5 years of relevant experience
• Requires strategic thinking and ability to work independently.
• Bachelor’s degree or equivalent experience, preferably in biology, Chemistry, Microbiology, or related science
• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
• Advanced degree preferred
• Ability to represent the department in regulatory inspections.
• Minimum of 3 years of working experience in a cGMP regulated environment
• Experience with deviations, investigations, and CAPAs is required
• Fluent in speaking/writing in English
• Knowledge of cGMP, ISO, FDA, PMDA, USP, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
• Extensive experience with molecular assays.

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