Manager, Component Laboratory

Blood Bank of Delmarva, Inc.; Newark (DE); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full Benefits

Job summary

Blood Bank of Delmarva, Inc. is seeking a Manager for the Component & QC Laboratory at the Christiana Donor Center/Headquarters in Newark, DE. You will oversee the blood component manufacturing and quality control testing labs, ensuring safety, purity and potency per FDA/AABB guidance.

You will lead staff, develop SOPs, manage budgets, and drive corrective actions and CAPAs while maintaining rigorous documentation and regulatory compliance across all lab activities.

Qualifications

• Bachelor's degree in biology, chemistry, MLS or related science.
• Associate Degree in MLT with 6+ years in a moderate/high complexity lab.
• 4+ years of laboratory experience in a regulated environment.
• 2+ years in leadership/people management.

Responsibilities

• Manage operation and staffing of blood component manufacturing and QC testing labs.
• Ensure products meet cGMP, FDA, AABB and other regulatory requirements.
• Train, mentor and develop assigned staff; enforce SOPs and policies.
• Plan and direct processing, production, and QA activities to meet goals.
• Review and maintain documentation for receiving, manufacturing, labeling, and QC.
• Lead deviations investigations, CAPAs, and corrective actions.
• Assist budget development and monitor variances; cost analysis for equipment.
• Coordinate audits and ensure timely responses and documentation.

Skills

Leadership experience

Laboratory experience

Quality control

Education

Bachelor's Degree in Biology/ Chemistry/ Medical Laboratory Science

Associate Degree in Medical Laboratory Technology (MLT) with 6+ years experience

Job description

Blood Bank of Delmarva

Christiana Donor Center/Headquarters - Newark, DE

Join our life saving mission!

• Full Benefits***

The Manager, Component & QC Laboratory position is responsible for managing the operation and staffing of the blood component manufacturing and quality control testing laboratories; ensuring that all products meet cGMP, the safety, purity and potency requirements of the FDA, AABB, and other regulatory agencies.

• Manages, trains, mentors, and develop assigned staff.
• Ensures adherence to SOPs, regulations, guidelines, practices and policies.
• Creating and revising SOPs and other controlled documents.
• Plans and directs the processing and production functions of the laboratory in order to meet goals.
• Ensure appropriate staff scheduling to meet business needs.
• Reviews and maintains documentation associated with receiving, manufacturing, and labeling of blood components.
• Reviews and maintains documentation associated with quality control of blood components.
• Troubleshoots and resolves technical problems and investigates and corrects errors.
• Assist in preparing, developing and monitoring annual budget for each cost center and analyzes and explains any variances.
• Perform cost analysis on equipment purchases, system enhancements, reagents, rental/leasing agreements.
• Manage deviations by investigating, ensuring appropriate corrective and preventive actions are complete, and documenting findings and actions.
• Write and manage validation, verification, and qualification protocols.
• Assist in coordinating department response to audit findings and other CAPAs.
• Assist in the development of new products, in accordance with FDA regulations.
• Ensure that quality control is performed and acceptable. Resolve any problems associated with quality control.
• Ensure that equipment maintenance is performed according to a pre-determined schedule.
• Assist with new computer software, equipment or test method validation, as required.
• Prepare various reports and track and trend departmental data points for assessing efficiencies and workflow.
• Participate and/or lead organizational committees and projects.
• Make recommendations to improve business unit practices and processes.
• Collaborate and communicate with others in the organization and enterprise.
• Attend training and remain current on industry information.
• Any related duties as assigned.

Education

• Bachelor's Degree in Biology, Chemistry, Medical Laboratory Science, or other related sciences.

OR

• Associate Degree as Medical Laboratory Technician (MLT) with a minimum of 6 years of post-graduate experience in a moderate to high complexity laboratory.

Experience

• 4+ years of experience in a Laboratory or other regulated environment.
• 2+ years of Leadership experience.
• Any combination of education, training, and experience equivalent to the requirements above that have supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

Preferred Qualifications

• Education Bachelor's Degree in Medical Laboratory Science with National Certification.
• Related Experience Blood Center Laboratory experience.

Founded in 1954, Blood Bank of Delmarva (BBD) has served the Delmarva Peninsula for over 70 years, delivering nearly 100,000 lifesaving blood products annually to 45+ hospitals, EMS and healthcare partners. BBD is part of New York Blood Center Enterprises (NYBCe), which operates in 16 states and delivers one million blood products to nearly 550 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.

NYBCe is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disabled status, or genetic information.