Assay Validation Scientist | Merck KGaA, Darmstadt, Germany

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

The Assy Validation Scientist is a 12 month FTC and  is to provide expert oversight of assay validation within the Glasgow site to ensure projects (including custom work) are carried out with the appropriate scientific and regulatory standards within Quality.  The Assay Validation Scientist will also ensure on time delivery and compliance with appropriate Quality and Regulatory standards.  The Assay Validation Scientist will assume all aspects of assay validation in line with appropriate quality driven requirements and regulations. 

Who you are:

• Work with Quality and Regulatory functions to monitor the compliance of assay validations.
• Act as an expert for assay validation within the department.
• Have direct involvement and interaction (with development services and operational staff) during performance of work to ensure the successful completion of assay validation projects.
• Monitor project timelines for all assay validation projects, working with team members to ensure that all milestones are met.
• Contribute to preparation of globally aligned protocol and report templates pertaining to assay validation studies.
• Work with development services, operations, and quality within UK and globally to ensure that all client and internal validation studies are delivered in a timely manner meeting all quality and regulatory requirements.
• Work with operational departments within area of expertise to update assays in line with the appropriate Validation Master Plan and client / regulatory expectations.
• Review and monitoring of assay performance, trending, and risk assessments to ensure assays remain in validated state.
• Support critical event / lab investigations within Biologics with respect to assay validation.
• Act as the assay validation consultant for clients, providing input into the design of assay validations
• Liaise closely with client representatives to ensure their expectations are met or exceeded. 
• Provide scientific coaching and mentoring in assay validation to other staff members (training and scientific support for ongoing projects).
• Monitor industry trends to ensure that the business remains at the forefront of scientific advancements in the field of Biologics; review and recommend potential technical developments to senior / executive management.
• Promote a culture of continuous improvement within Biologics act as champion on initiatives and/or projects to drive improvement in quality and / or client service.
• Provide assay validation advice and support for client and regulatory interactions (audits, meetings, teleconferences, and inspections.
• May perform other related duties as required and / or assigned.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!