Biobank Excellence Lead

Job Title: Biobank Excellence Lead

Location: Gaithersburg, MD

Introduction to role

AstraZeneca ‘s industry leading Biocentre will house up to 20 million Human Biological Samples to accelerate science and delivery for patients. The Biocentre will be a state-of-the-art, automated, digitally connected global hub for our Human Biological Samples (HBS). Human Biological Samples (HBS) are fundamental to medical research in discovering, developing, and implementing new treatments and diagnostics. HBS are ethically sensitive materials and underpin the delivery of every clinical trial.

The Biobank Excellence Lead plays a central role in ensuring operational excellence across Biobank Network sites by identifying, leading, and managing global improvement initiatives while ensuring operational and strategic standardization across all sites. Key responsibilities include managing and updating the Biobank Playbook, ensuring Biobank operations excellence with respect to the established standard, and providing practical preventions and corrective action plans for all types of nonconformance issues. Additionally, the role encompasses identifying and developing proposals and business cases, tracking, and reporting KPIs as needed.

Accountabilities

• Lead and manage the development of global biobank strategies, processes, and systems, ensuring standardization across the Biobank Network​

• Monitor and report on global adherence to service delivery standards and provide related management information to the wider biosamples team​

• Assess and identify areas for improvement in global lab operations and efficiency gains across the Biobank Network​​

• Identify and resolve global operational issues within lab processes, equipment, and systems, liaising with IT, C&G, etc to deliver technical support​

• Develop business cases to acquire funding & resources for global improvement initiatives / proof of concepts, and oversee project planning​

• Identify best practices for efficient ways of working globally, including the organization and facilitation of cross-site knowledge transfer​​

• Lead the drafting, maintenance and review of all Biobank-related procedural documents (SOPs, Work Instructions, Templates, Checklists etc…) and maintain expert-level knowledge of Biobank Network lab procedures​

• Own the Biobank Network Op Model Playbook, coordinating updates, and making versions available to biobank teams both in digital and physical formats​

• Drive and embed a culture of customer-centricity and continuous improvement through engagement with HBS User Groups across all sites​

• Proactively provide corrective action plans for non-conformance issues across all sites, and support with innovative approaches for practical prevention​​

• Define standardised Biobank performance metrics and governance reporting process for each site​

• Monitor, report and maximise the ROI of Biosample Data​

• Monitor and analyse metrics on the operational activities of Biobank Network sites and assess for global opportunities and risks, including performance metrics for global Biobank Network improvement projects​

• Support US and EU Biobank Leads by providing updates on performance metrics and insights gained from working closely with global biobank staff to assist with strategy-setting and decision making​

• Define the scope and lead the operationalisation of the DNA lab at the Biocentre, providing ongoing scientific, technical, and application support for associated DNA lab capabilities​

•  Assist Biobank Leads with the local operational implementation of Biobank Network global strategy to ensure consistency across labs is established and maintained globally​

• Support Biobank Leads & Biocentre Services Lead with implementation of new innovations or approaches to improve biobank services​

• Ensure up to date knowledge and experience with end-to-end biobanking activities in order to provide input and support when required​

• Provide expert guidance and advice and ensure work is performed in accordance with global standards e.g. SHE, SOPs, Good Clinical Practice and legal requirements.

Essential Requirements:

• Master’s/Ph.D degree in a scientific discipline

• Experience in:​

• oBasic laboratory practices

  o​Clinical research

  oUnderstanding basic database systems (LIMS)

  oLeading research initiatives involving Biobank samples

• Biobank Services Lead, Biobank Director

• Global biobank teams
  

Desirable Skills/Experience

• Experience in Biobanking

• Experience in Project Management

• ISBER certifications

• Knowledge of Regulatory areas- FDA, CLIA, ISO

• GLP training

• Courses or workshops in strategic planning

• Communication and stakeholder management

• Vendor organizations

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.

Ready to make a difference? Apply now!

The annual base pay (or hourly rate of compensation) for this position ranges from 134,892.80 - 202,339.20 USD Annual.  Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.