Bioanalytical Scientist

Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts. Duties / Responsibilities Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform review of testing data (e.g., data packets, final lot file, COA review). Anticipate and perform complex troubleshooting and problem solving independently. Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products. Own project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts. May represent the department in regulatory inspections (internal and external audits). Train and mentor others on multiple QC test methods, processes and procedures. Cross trained on multiple complex analytical methods and/or multiple products. Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate. Perform other tasks as assigned. Qualifications - Specific Knowledge, Skills, Abilities Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred. Strong mentoring, coaching, influencing, negotiating and personnel interaction skills. Education / Experience / Licenses / Certifications Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred. 4 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique). Reporting Relationship This position will report to QC management. 100% onsite This position is 100% onsite. Work Schedule Mon‑Fri (normal business hours). Compensation The starting hourly compensation for this assignment is $40 – $44.63 per hour. Equal Opportunity Employer. #J-18808-Ljbffr Bristol Myers Squibb