Senior Data Reviewer – Small Molecule

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🔥 29 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 • Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner • Escalates significant deficiencies to the project leader or supervisor for assessment • Trains new Data Reviewers and laboratory staff in basic and complex analytical data review • Mentors junior data review staff in review process • Advocates the departmental manager or supervisor in the evaluation of the laboratory Data Review process and assists in assigning work to self and others • Identifies and drives process improvement initiatives

🎯 Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification • 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 • 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 verbal and written communication skills • Strong attention to detail • Ability to balance time and remain focused on work to meet goals • Ability to train and mentor junior data review and lab staff • Ability to provide clear and concise feedback and/or documentation of results • Ability to work in a collaborative team environment

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible work arrangements • Professional development