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Thermo Fisher Scientific · 5 hours ago

Scientist, Characterization

Framingham, MA

Full-time

Onsite

Entry, Mid Level

$36/hr - $38/hr

2+ years exp

Thermo Fisher Scientific is a leading global contract research organization focused on making the world healthier, safer, and cleaner. The Scientist, Characterization will perform complex sample preparation and analysis procedures for pharmaceutical and biopharmaceutical compounds, ensuring quality and compliance with regulatory standards.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Daily equipment preparation and calibration

Assist with testing schedule maintenance and coordination

Provide assay support. This includes HPLC/UPLC, Electrophoresis (SDS PAGE, CE-SDS, iCiEF), and Spectrophotometric

Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing

Problem solves with assistance pertaining to extraction and/or instrumentation problems

Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines

Communicates project status to project leader

Performs work assignments accurately, and in a timely and safe manner

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)

Performs self and peer review of the data in iLab (electronic lab notebook) for accuracy and compliance with reporting requirements

Qualification

HPLCBiopharmaceutical experienceEmpowerGMP knowledgeRegulatory guidelinesProblem solvingTime managementCommunication skillsCollaboration

Required

Must be legally authorized to work in the United States without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Immunology, Chemistry, Biology, Molecular Biology or similar

Previous experience provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years') or equivalent combination of education, training, and experience

OR Master's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1+ year)

Biopharmaceutical industry preferred

Preferred

Demonstrated knowledge of one or more applicable techniques such as: HPLC, SEC, CE, icIEF

Experience with HPLC and Empower, and method optimization and troubleshooting

Knowledge of applicable regulatory authority, compendia, and ICH guidelines

Ability to understand and independently apply GMPs and /or GLPs to everyday work about documentation and instrument use

Ability to utilize Microsoft Excel and Word to perform tasks

Good written and oral communication skills

Time management and project management skills

Problem solving and troubleshooting abilities

Ability to work in a collaborative work environment with a team

Benefits

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