Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Join us as Senior Data Reviewer - Cell and Molecular Biology!
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. This role is for our GMP Lab in Athlone where we provide analytical testing support to our clients.
As a Senior Data Reviewer in the Cell & Molecular biology lab, your role will be to perform review of a variety of complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations.
This is the perfect job for someone who has strong review experience, Cell & Molecular experience and is looking to move away from hands on lab duties.
What You’ll Do:
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.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years QA/QC lab analytical /lab data review experience is essential ( gaining thorough knowledge of cell techniques such as bioassay experience, mammalian cell culture, flow cytometry, PCR including experience in reviewing analytical data/results)
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 and 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
Working Conditions and Environment:
- Work is performed in an office environment, either in an on-site or remote capacity with exposure to electrical office equipment.
- Remote work environment should remain free of outside distractions. Occasional drives to site locations may be required.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Requires multiple periods of intense concentration.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthrough.
We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant.
