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At Azenta new ideas new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
Azenta Life Sciences is aglobal leader in the life sciences space with headquarters in Burlington MA and offices and operations worldwide. We area market leader in automated bio sample management solutions and genomic services across areas such as drug development clinical and advanced cell therapies for the industrys top pharmaceutical biotech academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis sample management and storage services informatics software and consumables with the largest installed base managing over 1 billion samples globally.
How Youll Make an Impact
The Biobank Manager is responsible for hands-on leadership of sample management operations including but not limited to making good judgment regarding the use of resources; human equipment and/or time to meet commitments and customer expectations and to develop/report corresponding metrics. The incumbent is also responsible for ensuring compliance with quality standards in a regulated environment (regulated by NABP/DDA BoP CAP FDA EMA NRC etc).
What Youll Do
Manage all aspects of the Biobank department including personnel productivity general inventory departmental metrics and reporting. Drive a strong quality culture by enforcing all policies and procedures with attention to Quality and regulatory compliance to applicable standards which includes but is not limited to:
National Association of Board of Pharmacies (NABP) Drug Distributor Accreditation (DDDA) compliance.
State Board of Pharmacy (BoP) and Tissue regulations
College of American Pathologist Biorepository Accreditation Program (CAP BAP) and Clinical Laboratory Improvement Amendments (CLIA)
US Food and Drug Administration
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Good Tissue Practices (GTP)
Good Distribution Practices (GDP)
European Medicines Agency (EMA)
Japanese Pharmaceutical and Medical Devices Agency (PDMA)
Nuclear Regulatory Commission (NRC)
International Organization of Standards (ISO) 9001
Ensure storage shipment and corresponding record-keeping is maintained for regulated pharmaceuticals. Develop and monitor productivity and performance standards. Plan and direct workflow and project assignments. Implement best practices to drive standardization and streamlined processes regulatory compliance and efficient use of resources. Contribute to Sales and Operations planning to ensure resources execute on client demands for receipt registration retrieval outbound shipping and sample discard. Ensure that all material movement by personnel is accompanied by timely and accurate system transactions. Support Quality Assurance in hosting and providing follow-up for client and regulatory audits. Communicate regularly with Sales account managers and develop relationships with targeted clients. Promote culture of continuous process improvement by leading participating and implementing improvements. Act as subject matter expert for Sales Project/Program Management and/or Informatics to guide project execution or for enhancements to system functionality to improve quality and resource and workflow efficiency. Independently follow through on assignments to provide assistance guidance problem solving or feedback. Support client inquiry responses and issue resolution as needed for timely and accurate resolutions. Ensure all service failures are identified investigated and reported appropriately.
Your Management Responsibilities
Hiring & Staffing
Collaboration
Communication to Inspire & Empower
Performance Management
Develop People
What Youll Bring
EOE M/F/Disabled/VET
Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race color age religion gender sexual orientation gender identity national origin disability or veteran status.
Required Experience:
Manager
Full-Time