Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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 samplesWork and assist with LCMS R&D Team on LCMS methods devolvement and methods transferFollow FDA /ISO requirements and all Quality Systems Requirements, research, design and develop methodologies, techniques, verification/validation criteria, and manufacturing processes of clinical assays and reagentsDesign and interpret experiments and results to meet key design and end-user requirements. Work with Project Management to capture and manage work in project planWork 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 processTest and validate assay performance under clinical settingsSuccessfully transfer assay reagents to manufacturingTrain and support others including field based applications and service teamTroubleshoot and resolve issues with assay reagents and methodsCreate field service tickets, clearly reporting issues, and collaborating with Field EngineersPerform other responsibilities to support the needs of the department as assignedFollow SOP and GMP, GLP to do routine analytes and report

Job Requirements and Qualifications

BS/BA with 8+ yrs experience, MS with 5+ yrs experience or a Ph.D with 1-3yrs experience (including any post-doctoral experience) in analytical chemistry, biochemistry, clinical chemistry or related fieldFamiliar with design control and regulatory requirements related to IVD productsDirect experience working in a product development group in an IVD / medical device industry under relevant cGMP, FDA or ISO regulatory requirements is a plusExperience with formal OOS and CAPA investigation and documentation is preferableFamiliar with quantitative bio-analytical LC-MSMS technology, equipment, method development and validation, data analysis and softwareHand-on experience in a clinical test lab using LC-MS,MS equipment and human clinical samples is also a plusStrong communication and interpersonal skills including ability to articulate and present complex experimental details and results effectivelyExcellent time-management, planning and organization skills to handle and efficiently manage high workload and meet timelinesSolid understanding of Windows based applications, internet technology, and statistical analysis software is vitalEffectively working with different teams in group setting or individual setting to meet deadlines for customersProficient in ordering testing supplies for LCMS testing and supervising supply levelsWillingness 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–$133,300.00.

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