Sr Data Reviewer - Small Molecule

About the role

This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applications from all locations within the US. Must be legally authorized to work in the United States without sponsorship.

Responsibilities

• 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.
• 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 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.

Requirements

• Education: Bachelor’s degree or equivalent and relevant academic/vocational qualification.
• Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

Qualifications

• Knowledge: Previous experience with formal data review in GMP Lab strongly preferred.
• Skills: Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP; thorough knowledge of chromatography may be required.
• Abilities: 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.

Benefits

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• 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, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Pay

Competitive compensation package.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards