Sr Data Reviewer, Biopharma - Remote

Sr Data Reviewer- Remote, Biopharma  

At PPD, part of 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, 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. 

Location/Division Specific Information 

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

Discover Impactful Work: 

The role of Sr Data Reviewer is to support our Laboratory teams in ensuring the integrity and quality of laboratory and chromatographic data and reports. They Perform review of a variety of complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices. Sr Reviewer 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. They also ensure 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).

This is the perfect job for someone who has strong review experience and is looking to move away from hands on lab duties. 

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

Education and Experience 

• BSc in Science or related field required 

• 5+ years of QA/QC experience required (gaining thorough knowledge of chromatography and including experience in reviewing analytical data/results) 

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

• Strong verbal and written communication skills 

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

• Ability to train and mentor junior data review and lab staff

• Ability to independently review laboratory reports and analytical methods 

• Strong attention to detail 

• Ability to provide clear and concise feedback and/or documentation of results 

Work Environment  

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.