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 a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's 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 You’ll 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 You’ll 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
- Skills assessment
- Resource planning
- Competency based, quality hiring
- Effective on-boarding
Collaboration
- Constructive conflict
- Appropriate follow-up
- Holds self and other accountable
- Builds relationships & partners across-functions
- Considers and communicates cross-functionally
Communication to Inspire & Empower
- Regular meaningful communications
- Connection of department & individual purpose to strategic direction
- Follow-up to address obstacles
Performance Management
- Reinforce behaviors that drive results
- Assess -right person in the right job
- Feedback/coaching
- Raising the bar; increasing contribution
- Address misaligned or misplaced talent
Develop People
- Dialogue about skills & behaviors for success at Azenta
- Understanding employee aspirations
- Opportunities for experiential learning & growth
- Experience planning & delegate to develop
What You’ll Bring
- Bachelor’s degree with 3+ years of people and functional leadership experience
- Associate’s degree with 5+ years of people and functional leadership experience
- High School Diploma with 7+ years of people and functional leadership experience
- 5+ years of experience in a life sciences related regulated industry (CLIA, CAP, GMP, GTP, GLP, BoP)
- Preferred
- 3+ years biobank management experience
- 5+ years of experience in management of pharmacy or pharmaceutical distribution
- Demonstrated initiative and the ability to organize multiple activities on a daily basis
- Ability to analyze and make good judgment decisions
- Ability to work collaboratively and serve as a leader among colleagues
EOE M/F/Disabled/VET