Senior Specialist, QC Microbiology, Cell Therapy

About the role

Responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Train and mentor others on QC test methods, processes, and procedures. Perform other tasks as assigned.

Responsibilities

• Perform method transfer/verification/validation, routine testing of in-process, final product, and stability samples.
• Perform environmental/facilities monitoring and microbiological testing.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Perform data verification, data review and review of GMP documentation for general and complex methods.
• Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Train and mentor others on QC test methods, processes, and procedures.
• 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. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Education/Experience/Licenses/Certifications: Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred. Netherlands MLO level 4 required. 4+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience with microbiological techniques.

Benefits

Compensation Overview: Starting hourly range $40.97 - $49.64. Additional incentive cash and stock opportunities (based on eligibility) may be available. Benefits include Health Coverage, wellbeing support programs, financial well-being and protection, and work-life benefits. For more details, visit careers.bms.com/life-at-bms/.