Director, Component & QC Laboratory

Christiana Donor Center/Headquarters - Newark, DE

Join our life saving mission!

• Full Benefits***
  
  
  

The Director, Component & QC Laboratory position is responsible for the operation and management of the cGMP blood component processing laboratory; ensuring that all products meet the safety, purity and potency requirements of the FDA, AABB and other regulatory agencies. Responsible for business continuity and optimizing manufacturing to meet inventory needs. This position is considered “essential” during severe weather or emergency operation events.

• Responsible for processing and production functions of Component manufacturing and quality control laboratories.
• Develops and implements SOPs and ensures compliance with regulations and cGMPs.
• Prepares, develops and monitors budget and maintains cost by implementing productivity and efficiency gains.
• Directs, mentors, trains and develops assigned staff ensuring all competencies are performed.
• Trouble shoots, investigates and resolves complex and technical problems associated with lab operations.
• Ensure that current good manufacturing practices are evident in all component manufacturing functions.
• Provide guidance and expertise to ensure proper error management and root cause analysis to minimize risk and waste.
• Promote the development and implementation of corrective/ preventative actions resulting from errors and audit findings.
• Create department goals that support the local and Enterprise strategic goals.
• Responsible for the department's annual budget, including tracking department revenues and expenses.
• Recommend and implement changes to improve business unit practices, processes, and efficiencies.
• Promote staff engagement and communication of organization goals and changes that impact the department.
• Facilitate standardization between divisions to align with Enterprise goals.
• Prepares various reports and track and trend departmental data points for assessing efficiencies and workflow.
• Participate and/or lead organizational committees and projects.
• Routinely collaborate and communicate with others in the organization and enterprise.
• Attends and participates in conferences and seminars.
• Remain current with industry practices.
• Any related duties as assigned.
• Exemplifies BBD’s Customer Service Mission and Core Values.
  
  
  

Education

• Bachelor’s Degree in Medical Laboratory Science, Biology, Chemistry, or other related science to meet CLIA moderate complexity requirements of a Technical Consultant (TC).
  
  
  

Related Experience

• 4 years experience in blood banking, component processing, experience in cGMP Biologics manufacturing operations and experience assuring compliance with safety and cGMP requirements while adhering to a biologics manufacturing schedule.
• 3 years of leadership or supervisory experience.
• Knowledge of AABB, FDA, OSHA, and regulations
• Working knowledge of Microsoft Suites
• Working knowledge of BECS
• Working Knowledge of Good Manufacturing Practices (cGMP)
  
  
  

Founded in 1954, Blood Bank of Delmarva (BBD) has served the Delmarva Peninsula for 70 years, delivering nearly 90,000 lifesaving blood products annually to 40 hospitals, EMS and healthcare partners. BBD is part of New York Blood Center Enterprises (NYBCe), which spans 17 states and delivers one million blood products to 400 U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200 research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. BBD serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit delmarvablood.org. Connect with us on Facebook, X, Instagram, and LinkedIn.