Cell Lab Data Review Scientist, Remote - Athlone, Ireland

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work across our 3 laboratory groups: Biopharm, Small Molecule, and Inhalation.

The role of Cell lab Data Review scientist is to ensure the quality of laboratory data and reports.

Key responsibilities

• Ensures data compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).
• Performs complex analytical data reviews ensuring scientific soundness and method validation.
• Reviews cell, molecular biology or immunochemistry assay data and related documentation as specified by Standard Operating Procedures (SOPs).
• Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Prepares statements noting deficiencies with the analytical data set or documentation.
• Reports deficiencies to the project leader for correction.
• Trains new data Reviewers and Cell & Molecular Biology laboratory staff. Performs other duties as assigned, including SOP review and writing.
• Conducts consultations for quality records.

Education and Experience

• Degree or equivalent in Life science biochemistry, immunology or cell biology
• Ability to independently review laboratory reports and analytical methods
• Experience in cellular and immunologically based assays
• Ability to utilize Microsoft Excel and Word to perform tasks
• Proven ability in technical writing skills
• Proven problem solving and troubleshooting abilities
• Time management and project management skills
• Good written and oral communication skills
• Ability to work in a collaborative work environment with a team as well as working off own initiative.
• Ability to train/mentor junior staff.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

• Pension scheme
• Annual Leave 25 days
• Medical Health care cover
• Life Insurance

If you ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you. 1

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Thermo Fisher Scientific is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. Thermo Fisher Scientific is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.