Scientist III Microbiology
Scientist III Microbiology
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$ 100000 - 149950
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)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 materialsJob 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 inprocess 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 crossfunctional teams to develop contamination control strategies and aseptic process manufacturing controls.
- Support site safety initiatives.
Education
Bachelors degree or equivalent experience in science preferably Microbiology or Biology or related lifesciences field. Minimum 5 years of proven experience in a cGMPregulated 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 productspecific 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.
At Thermo Fisher Scientific every one of our 70000 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!
Compensation and Benefits
The salary range estimated for this position based in California is $100000.00$149950.00.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 longterm 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
Employment Type
Full-Time
Key Skills
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