Senior Data Reviewer – Biopharm

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🔥 10 minutes ago

🧀 Wisconsin – Remote

🧀 Wisconsin – Remote

⏰ Full Time

🟠 Senior

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Performs review of a variety of complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices. • Possess a thorough understanding of laboratory procedures and can reliably conduct routine, non-routine (method establishment), and complex analytical data review ensuring scientific soundness and adhering to method validation. • Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). • Reviews data entered into databases and reports and monitors the quality and scientific soundness of the laboratory data. • Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness. • Trains new Data Reviewers and laboratory staff in basic and complex analytical data review. • Mentors junior data review staff in review process. • Identifies and drives process improvement initiatives.

🎯 Requirements

• Bachelor’s degree or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience. • Previous experience with formal data review in GMP Lab strongly preferred • Previous experience with Biopharmaceutical techniques preferred • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP • Thorough knowledge of chromatography may be required • Strong technical knowledge of method validation and probable cause evaluation • Strong technical knowledge including an understanding of laboratory procedures, methodology and standards • Strong attention to detail • Ability to train and mentor junior data review and lab staff

🏖️ Benefits

• Health and wellbeing support • Employee training programs • Career development opportunities