Senior Data Reviewer - Method Establishment Review, Small Molecule

Discover Impactful Work

Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOPs and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

A day in the Life

• 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

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Experience

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 may be required.
• To demonstrate behaviours 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.
• 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 independently review laboratory reports and analytical methods with minimal oversight.
• Ability to deal with multiple and changing priorities.
• Ability to provide clear and concise feedback and/or documentation of results.
• Ability to work in a collaborative team environment.