Senior Data Reviewer (GMP Lab, Biopharmaceutical)

About the position 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.

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.
• 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.
• 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.

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). 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.
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• Demonstrated experience reviewing analytical data generated from method development, method qualification, method verification, or method validation studies preferred
• 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
• 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
• 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 for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.