Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Senior Data Reviewer

Department: Small Molecule

Role Details: Remote, Full Time

This is a fully remote role supporting our GMP Lab in Middleton, Wisconsin. We welcome applicants from all locations within the US.  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. 

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Role Overview:

Performs review of a variety of complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations. Possesses a thorough understanding of laboratory procedures and can reliably conduct routine, nonroutine (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.

Role Responsibilities:

• Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness.

• Reviews development analyses of non-routine projects. Performs analytical data review of method qualification, verification, and validations interpreting the data for compliance and technical soundness.

• Performs reviews routine and non-routine protocol and methods.

• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.

• 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 for quality and review process changes.

• Assists 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

• Performs other duties as assigned.

Keys to Success:

Education & Experience

• 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).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP

• Thorough knowledge of chromatography.

• To demonstrate behaviors which align to the 4i Values of Thermo Fisher

• Strong technical knowledge of method validation and probable cause evaluation

• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards