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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, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Scientist III, QC Microbiology

Join Thermo Fisher Scientific to make a global impact through meaningful work every day.

Location / Division Specific Information

Work onsite in San Francisco, CA at CTx Thermo Fisher Scientific. We advance cell therapies for cancer, rare diseases, and other conditions.

What you will do

+ Perform all functions within the QC Microbiology laboratory ensuring site compliance with regulatory and corporate requirements.

+ Coordinate work schedules for the team and be accountable for daily laboratory activities to ensure flawless quality output.

+ Ensure testing is performed accurately and timely to meet production schedules and project timelines, including microbial limits, routine EM, sterility, growth promotion, etc.

+ Coordinate testing for incoming raw materials, facility environmental monitoring, in-process, cell banks, and formulated drug products.

+ Author, revise, and review specifications, SOPs, and other documents related to the QC Micro Lab.

+ Train new hires on department processes, procedures, and tools.

+ Lead quality event investigations and provide resolutions to issues arising from QC Micro laboratory operations.

+ Represent the QC micro department during audits, inspections, and site visits.

+ Validate and verify microbial methods ensuring alignment with regulatory and company requirements.

+ Review and approve documentation and data generated by the laboratory.

+ Communicate effectively with colleagues across manufacturing, engineering, AD/PD, and QC staff to resolve technical issues and direct activities.

+ Support cross-functional teams to develop contamination control strategies and aseptic process manufacturing controls.

+ Support site safety initiatives.

Education

Bachelor's degree or equivalent experience in science, preferably Microbiology or Biology, or related life-sciences field. Minimum 5 years of proven experience in a cGMP-regulated lab setting.

Experience

+ At least 2 years of team lead experience in a Quality/Analytical role within the pharmaceutical industry.

+ Knowledge of QC microbiology techniques is required with experience in cGMP regulated laboratory environment.

Knowledge, Skills, Abilities

+ Ability to drive functional, technical, and operational excellence.

+ Firm knowledge of cGMP regulations.

+ Technical expertise with compendial and product-specific QC microbiology methodologies.

+ Good interpersonal and communication skills, both written and oral.

+ Proven understanding of applicable regulatory requirements as it relates to analytical method transfer, microbial verification, ICH, USP, etc.

+ Demonstration of a logical approach to solving scientific problems.

+ Experience in leading a team responsible for performing Environmental Monitoring, including interpreting results and conducting thorough investigations.

+ Proficient in analyzing Environmental Monitoring results, EM Reports, identifying trends, and making informed decisions based on these investigations and trends.

+ Proven technical troubleshooting analytical instrumentation and problem solving abilities

+ Excellent written and oral communication skills

+ Ability to implement quality systems and process improvements

+ Demonstrated coaching and mentoring skills

+ Strong organizational agility and demonstrated drive for results

At Thermo Fisher Scientific, every one of our 100,000 outstanding minds has an exceptional story to share. Join our remarkable mission of empowering our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Compensation and Benefits

The salary range estimated for this position based in California is $100,000.00–$149,950.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

+ 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.