About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite once per quarter in our Bourne office, UK.
Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
We're looking for a dynamic Biosample Operations Manager to lead and execute biosample management activities with precision and impact. This role involves overseeing vendor relationships, providing training, and working closely with study teams to drive process improvements.
You’ll also manage biosample operations systems, ensure smooth sample tracking, and play a key role in system administration. You’ll work independently while collaborating with fellow Biosample Operations Managers, the Lead, and the Department Head to achieve shared goals.
If you’re ready to take on a pivotal role in biosample management, we’d love to hear from you!
Role and Responsibilities
• The Biosample Operations Manager (BOM) is responsible for managing all operational aspects of study implementation and maintenance within the sample management system. Additionally, serving as a key resource for biosample management best practices.
• Key responsibilities include sample management tasks, with the flexibility to take on other duties or special projects as needed.
• Overseeing study setup in the Sample Management system, liaises with study teams, vendors, and ensures timely project rollout. Providing system training, contribute to team discussions, and maintaining lessons learned and evaluation documents for review.
• Supporting the maintenance of quality documents related to biosample management, ensuring they remain current and accurate and updating Biosample Operations Work Instructions and Templates. You may also be participating in vendor evaluations, such as for new technologies or laboratory CRO selection. Additionally, you might be contributing to process improvement initiatives and the development of SOPs or other quality documents.
• Identifying training needs and helping develop sustainable training materials. You’ll also be supporting the ongoing review of these materials to ensure they stay current, accurately reflect BSMO processes, and are properly deployed to relevant departments and job functions.
Required Qualifications:
• Bachelor's degree or equivalent with scientific or clinical background, study management experience preferred.
• Solid experience in pharmaceutical, clinical research or health services industry with experience as clinical study manager, central laboratory project manager, data manager, or project manager.
• Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents.
• Experience with protocol and clinical drug development processes.
• Maintaining the BSMO SharePoint site.
• Proven project management skills and leadership ability.
• Excellent interpersonal, written, and verbal communication skills and computer ability.
Preferred Qualifications:
• Experience with Biosample Tracking/Management is preferred.
• Ability to apply GCP, clinical operations, and scientific knowledge in planning, managing, reviewing data, and reporting biosample-related information.
• Skilled in reading and understanding clinical protocols, especially regarding the collection, processing, storage, and shipment of critical specimens (e.g., PK, PD, Biomarkers) in line with protocol and relevant guidelines.
• Strong problem-solving and critical thinking abilities, able to identify root causes and implement corrective actions within GCP regulations, SOPs, protocols, and industry best practices.
• Demonstrates proactive thinking, anticipating problems and taking action to prevent them.
• Highly motivated, self-directed, and reliable in following through on commitments with strong presentation skills, ensuring both verbal and visual content is clear and well-organised.
• Communicate effectively, both orally and in writing, and can clearly explain experiences and issues. Additionally, they are highly organised, staying on top of tasks and project milestones.
What awaits you at Astellas?
• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organisational Values and Behaviors
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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