• 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 of Science degree in chemical or biological science (with minimum requirement of 6 credits of biology and 6 credits of chemistry completed) or BA in core sciences (approval is dependent on transcript review).

  OR

• Bachelor’s degree Medical Laboratory Science.

Related Experience:

• 7-10 years’ experience in clinical laboratory, 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.
• Any combination of training and experience that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

• Knowledge of AABB, FDA, OSHA, and regulations.

• Working knowledge of Microsoft Suites.

• Working knowledge of BECS.

• Working Knowledge of Good Manufacturing Practices (cGMP).

   

Preferred Experience:

• MLT, CLS or MT degree.
• Blood center operations.
• SBB or BB certification.

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.