Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, 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
The Clinical Diagnostics Division of Thermo Fisher Scientific is seeking a highly motivated, innovative and experienced professional to join the Quality Control department based in Fremont, California. This Scientist-III will be part of a team responsible for developing and running liquid chromatography - tandem mass spectrometry (LC-MSMS) based clinical assays in a FDA/ISO regulated environment.
Responsibilities
Perform sample preparation and LC-MS Sample quantification for measuring various analytes such as steroids, therapeutic drugs, opioids etc. in human serum, plasma, urine, whole blood, oral fluids or other samples
Work and assist with LCMS R&D Team on LCMS methods devolvement and methods transfer
Follow FDA /ISO requirements and all Quality Systems Requirements, research, design and develop methodologies, techniques, verification/validation criteria, and manufacturing processes of clinical assays and reagents
Design and interpret experiments and results to meet key design and end-user requirements. Work with Project Management to capture and manage work in project plan
Work cross-functionally to identify, quantify and mitigate design and process risks for e.g. via Failure modes and effects analysis (FMEA) or some other risk management process
Test and validate assay performance under clinical settings
Successfully transfer assay reagents to manufacturing
Train and support others including field based applications and service team
Troubleshoot and resolve issues with assay reagents and methods
Create field service tickets, clearly reporting issues, and collaborating with Field Engineers
Perform other responsibilities to support the needs of the department as assigned
Follow SOP and GMP, GLP to do routine analytes and report
Job Requirements and Qualifications
BS/BA with 5+ yrs experience, MS with 3+ yrs experience or a Ph.D with 1yr experience (including any post-doctoral experience) in analytical chemistry, biochemistry, clinical chemistry or related field
Familiar with design control and regulatory requirements related to IVD products
Direct experience working in a product development group in an IVD / medical device industry under relevant cGMP, FDA or ISO regulatory requirements is a plus
Experience with formal OOS and CAPA investigation and documentation is preferable
Familiar with quantitative bio-analytical LC-MSMS technology, equipment, method development and validation, data analysis and software
Hand-on experience in a clinical test lab using LC-MS,MS equipment and human clinical samples is also a plus
Strong communication and interpersonal skills including ability to articulate and present complex experimental details and results effectively
Excellent time-management, planning and organization skills to handle and efficiently manage high workload and meet timelines
Solid understanding of Windows based applications, internet technology, and statistical analysis software is vital
Effectively working with different teams in group setting or individual setting to meet deadlines for customers
Proficient in ordering testing supplies for LCMS testing and supervising supply levels
Willingness to work on site and sometime on the weekends if needed
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation and Benefits
The salary range estimated for this position based in California is $100,000.00-$110,000.00.
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
