Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Will work with hazardous/toxic materials

Job Description

Scientist III, QC Microbiology

As part of the Thermo Fisher Scientific team you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our ethos to life every single day. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

• Perform all functions within the QC Microbiology while adhering to site compliance with cGMP testing principles and global regulatory and corporate requirements
• Build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement and cultivate a climate where staff are motivated to do their best.
• Overall coordination of work schedules for the team and be accountable for daily activities of the microbiological laboratory to ensure appropriate quality output.
• Ensure testing is performed in an accurate and timely manner to meet production schedule and project timelines including, but not limited to, microbial limits, routine EM, sterility, growth promotion, etc. for facility readiness, raw materials, in-process sampling, and final drug product formulations.
• Deliver analytical solutions to clients through expertise in Microbiological-specific method qualification and validation strategies.
• Serve as microbiology SME
• Responsible for the testing of incoming raw materials, facility environmental monitoring, in-process sampling, and final formulated Drug Product analytics.
• Author reports and supporting laboratory documentation
• Maintain key departmental metrics
• Revise/review specifications, SOPs, and other documents regarding QC Micro Lab
• Train new hires on department processes, procedures and tools.
• Leads investigations and provides resolution to test method issues and any quality events (i.e. deviations/OOS/OOT) arising from QC Micro laboratory operation and activities.
• Liaise with auditors/clients during visits and tours.
• Responsible for microbial method validation/verification ensuring the test methods are fit for their intended purpose and aligned with regulatory and company requirements.
• Review and approval of documentation and data generated by the group.
• Communicate articulately with colleagues within manufacturing, engineering, AD/PD and QC staff, to resolve technical issues and direct activities.
• Support cross-functional teams (MFG/MSAT) to develop contamination control strategy and aseptic process manufacturing control.
• Provide support to site Safety initiatives.
• Other job duties as assigned.

• Preferably at least 2 years of team lead experience in a Quality/Analytical role within the pharmaceutical industry.
• Knowledge of QC chemistry techniques is required, with experience with cGMP laboratory environment.
• Previous experience within a cell therapy CDMO is highly desirable

• Ability to drive functional, technical and operational excellence.
• Firm knowledge of cGMP regulations.
• Technical expertise with compendial and specific QC microbiology methodologies
• Good interpersonal and communications skills; written and oral.
• Extensive understanding of applicable regulatory requirements as it relates to analytical method transfer, microbial verification, ICH, USP, EU, etc.
• Demonstration of logical approach to solving scientific problems.

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount