Senior Data Reviewer – Method Establishment Review, Small Molecule

🔥 2 hours ago

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform complex laboratory analysis of pharmaceutical products using analytical instrumentation • Calculate, analyze and record data in adherence with PPD SOPs and industry requirements • Act as project leader on multiple projects and interact with clients • Review and evaluate data and write reports and protocols • Ensure scientific conduct of projects and communicate regulatory issues to senior team members • Independently perform method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds • Design and drive experiments with minimal supervision • Prepare study protocols, project status reports, final study reports and other technical documents • Communicate data and technical issues to clients and respond to client questions • Mentor, train and coordinate laboratory activities of team members • Troubleshoot instrument and analytical problems • Assist with quality systems and new equipment • Design method validation or method transfer protocols and establish project timelines • Review, interpret and analyze data for technical, quality and compliance with protocols, methods, SOPs, client criteria, GMP and GLP • Perform self and peer review of data before submission to QA and issuance to customers

🎯 Requirements

• Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience, or equivalent combination of appropriate education, training and/or directly related experience • Solid understanding and knowledge of general chemistry and separation science • Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance • Ability to apply Microsoft Excel and Word to perform tasks • Proficiency on technical operating systems • Proven problem solving and troubleshooting abilities • Effective oral and written communication skills • Proven technical writing skills • Time management and project management skills • Ability to work collaboratively with a team • Ability to train junior staff • Able to communicate, receive and understand information and ideas with diverse groups of people • Able to work upright and stationary and/or standing for typical working hours • Able to lift and move objects up to 25 pounds • Able to work in non-traditional work environments • Able to use and learn standard office equipment and technology with proficiency • May have exposure to potentially hazardous elements, including infectious agents, in healthcare or laboratory environments • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Resources to support individual career goals • Career development opportunities through meaningful scientific work • Mentoring and training opportunities • Health and wellbeing support • Healthy and balanced work environment

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