Validation - Technical/Scientific

At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
 

The Chemistry Department at Charles River Edinburgh is seeking a talented and flexible graduate or early career professional for a role as an Associate Application Specialist.

You will ideally be educated to a graduate level (preferably in a Scientific or Information Technology discipline but not essential).  Experience of working in a regulated environment (GLP/GMP) is preferrable but not essential.

In order to support our Agrochemical, Animal Health and Pharmaceutical Sponsors, the Chemistry department provides accurate quantification and elucidation of chemical structures using a range of chromatographic and spectrometric analytical techniques.  Each of these is underpinned by specialist laboratory equipment and computer software which must be adequately maintained to demonstrate continued fit-for-purpose status, robust data integrity and compliance with Company and Regulatory Agency expectations.

This involves working collaboratively with scientific staff, IT and Quality Assurance to ensure strict regulatory expectations are met regarding the capture, processing and secure storage of electronic data, whilst providing a practical and user-friendly support for scientific staff to conduct their work efficiently, effectively and with full trust and confidence in the data they produce.

The successful candidate’s role will be to maintain active computer systems in the Chemistry department, through implementing user access control requirements, troubleshooting reported errors and liaising with vendors.  They will also ensure systems remain relevant and fully compliant through regular reviews.  Completion and administration of documentation is an active part of the regular duties.  The successful candidate will be expected to continually modernise and to improve the compliance and usability of systems through introduction of new features in a controlled manner involving software/instrument testing and will be heavily involved in computer software qualification and validation efforts.

At the outset, the role is expected to be primarily office based as training and system familiarisation activities are undertaken but consideration to hybrid working will be considered. 

Accurate record keeping is imperative to ensure compliance with company and regulatory policies. We are therefore seeking a highly organised individual with an eye for detail. The successful applicant will have excellent communication skills, working effectively with others to overcome project challenges and learn new skills.  You will be proactive and have an analytical approach to problem solving and be able learn new computer software (including underlying administrative and compliance related features).  You will leverage your project management experience to overcome barriers to completion, maintain communication with stakeholders and ensure project timelines remain on track.

Intentionally, the role has no scientific data acquisition or data interpretation responsibilities on our Sponsor studies owing to potential conflict between oversight of regulated computer systems and data generation on the same system(s).

A working knowledge of instrument vendor software which underpin chromatographic and spectrometric techniques (examples such as Xcalibur, Compound Discoverer, Analyst, Sciex OS, LabSolutions, MassLynx) would be advantageous and speed familiarisation, but full training can be provided.

This role closes Tuesday, 14 May 2024 and the salary for this role is £27,163.48

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
 

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 
 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

For more information, please visit www.criver.com.