Blood Center Laboratory Manager

Secure Transfusion Solutions (“STS”) is an innovative high growth company modernizing America’s blood supply. The company’s mission is to restore hope, build trust, and improve quality of life by providing readily available and safe transfusion solutions. STS provides its customers—large and small—the peace of mind of knowing that they will receive a consistent and reliable supplemental source of blood components. The current blood component focus at STS is pathogen-reduced, single donor apheresis platelets. The collection and manufacturing practices at STS establish the highest standard of safety across the industry. STS builds and operates blood collection centers under the Trusting Heart Blood Center (“THBC”) brand.

YOU WILL LOVE OUR CULTURE IF YOU:

1. Obsess over quality in all facets of operations
2. Bring a day in, day out commitment to excellence 
3. Tackle big hairy problems with innovative and novel solutions
4. View work as much more than just a job: you thrive in a team-first, mission-driven environment
5. Take pride in being a reliable, trustworthy partner for customers, employees, and donors

READ ON IF YOU:

1. Are fired up about working with a diverse, mission-driven team striving to permanently solve one of mankind’s greatest challenges this century: fixing the unstable system that supplies hospitals with blood components used in patient care
2. Value being on the ground floor of an organization with boundless growth opportunities in the years to come
3. Thrive on providing internal and external customers the highest possible standards in service, quality, and reliability

Position: Blood Center Lab Manager

Location:  Location will be on site at one of the Trusting Heart Blood Centers; Edina, MN, Beaverton, OR, Raleigh, NC, or a future site to be determined

This position will be responsible for providing management oversight and direction to manufacturing lab staff in support of company’s initiatives including oversight of day-to-day operations. This position will be part of the Manufacturing (Lab) Department team and report to the VP of Manufacturing.

The Lab Manager will provide the leadership management, and the skills necessary to ensure the proper execution of developing and implementing trainings. This position will work closely with the senior leadership team and other leaders in the organization to ensure they understand the organization’s objectives, so they are creating training programs that are aligned with these objectives. Additionally, they will have a full understanding of training requirements from associated regulated agencies. The ideal candidate exhibits strong leadership skills, is self-driven, and has outstanding people skills.

The ideal candidate will have the ability to oversee daily operations, prioritize work, multiple tasks and assign duties in a dynamic work environment. This person will be expected to lead and manage change, drive the company’s core values, and have a strong understanding of the organization’s strategic direction. This person must be highly motivated and have an attention to details. The Lab Manager will be a site level leader with the ability to influence standards across the organization, lead and collaborate with customer facing issues and represent values of the organization.

DUTIES:

• Contributes to organizational mission via exemplary professionalism in customer service interactions and accuracy of work. The employee must be courteous, conscientious, and professional when dealing with both internal and external customers. Promotes teamwork and communication. Fosters a team environment to facilitate effective management of the manufacturing and distribution of blood and blood components. Reviews concerns and/or issues that may arise or threaten laboratory goals.
• Oversees, performs, and aids in the manufacture and distribution of blood components. This includes basic testing procedures, routine equipment cleaning and maintenance, and packing, shipping, and processing of blood components and donor samples.
• Provides input and support for the Blood Center Laboratory Director or designee to ensure blood component safety.
• Ensures all assigned laboratory operations are implemented, communicated, and conducted in compliance with current good manufacturing practice (cGMP), established regulations (FDA, CLIA), standard operating procedures (SOPs), criteria and industry standards (AABB).
• Provides technical support and consultation to aid in the resolution of testing or process issues to ensure the integrity of the blood component manufacturing process.
• Engages in/with resources to stay current on laboratory trends, process improvements, equipment, and testing/manufacturing advances. Researches and presents advances or changes needed to Executive leadership and interested parties. Implements and monitors laboratory changes or initiatives for success.
• Demonstrates understanding of established Code of Federal Regulations (CFR) and company SOPs, to ensure blood components meet safety, purity, and potency requirements.
• Ensures appropriate review and validation of SOPs are completed and all SOPs are current. Ensures appropriate communication and training of SOPs to laboratory employees.
• Model exemplary adherence to SOPs during performance of job tasks and ensures SOPs are enforced and consistently followed in the lab.
• Provides management and direction to teams in support of company initiatives. Reviews concerns and/or issues that may arise or threaten the manufacturing/distribution goals with the Lab Operations Director or designee.
• Assists the Blood Center Laboratory Director or designee and the Quality Regulatory Specialist (QRS) with CAPAs for any deviations or issues found during audits or observations.
• Maintains knowledge of blood components and qualities required to be tested for regulatory compliance, including statistically valid quality control (QC) testing.
• Appropriately operates and maintains equipment used in a moderate complexity testing laboratory in an effort to minimize cost of equipment maintenance and repair.
• Oversee and/or assists in problem solving of instrumentation or testing deviations.
• Maintains and oversees inventory management of reagents and supply levels ensuring operational needs are met without disruption. Responds to internal customer service requests regarding inventory requests.
• Escalates communication to appropriate stakeholders regarding compliance issues/concerns, blood component safety/integrity, and client satisfaction.
• Supports and participates in mandatory training, retraining, staff meetings, continuing education, and Current Good Manufacturing Practices (cGMP) training.
• Supervises, oversees and/or performs data entry associated with component production, labeling, storage, and shipping ensuring accurate and complete manufacturing records.
• Ensures suitability and accurate labeling of components for release and distribution.
• Operates, maintains, and performs or delegates quality control checks on equipment.
• Oversees and/or performs quality control on blood and blood components (according to State and CLIA requirements).
• Oversees and/or performs the quarantine and disposition of unacceptable blood components and samples.
• Conducts initial skills training, refresher training, and ensures routine assessment of employees in preparation for competency sign-off.
• Participates in validations, projects, and monitoring of routine key performance indicators.
• Provides leadership and technical expertise for the department helping to resolve issues associated with protocol, equipment, interpretation of test results and system interfaces.
• Ensures that all QC/QA procedures, maintenance schedules, instrument calibration and function checks and other regulatory inspection agency requirements are followed.
• Ensures and complies with all safety policies as stated in the company’s safety manual, SOPs, and work guidelines in local, state, and federal regulations and entities.
• Complies with personnel practices and confidentiality policies.
• Participates in local and/or national activities and organizations to maintain and have insight into industry knowledge, trends, and advances
• Performs other duties as assigned by Blood Center Laboratory Director or designee.
• Assist Blood Center Laboratory Director or designee in weekly and monthly quality indicator reports.
• Assists Quality & Regulatory team with inspections and accreditations
• Directly supervise Blood Center Laboratory Supervisor(s), Lab Technicians, and Distribution Specialists.
• Performs additional duties as assigned.

KEY COMPETENCIES

• Strong analytical and communication skills including working directly with all levels of staff
• Collaborative team player
• Organizational and leadership acumen
• Analytical Thinking and problem solving
• Excellent oral and written communications including following and developing SOPs
• Organized, consistent, and persistent with strong follow-up capabilities
• Able to independently navigate complex and changing environments

THE IDEAL CANDIDATE’S EXPERIENCE

• Bachelor’s degree in medical technology, clinical laboratory, chemical or biological science. In some circumstances, experience in lieu of education may be considered.
• Clinical laboratory training program or a minimum of five years of pertinent clinical laboratory experience
• At least two years of experience at the technologist level and one year of experience in blood bank or blood component manufacturing.
• Advanced degrees in clinical laboratory, chemical or biological science may compensate for less experience.
• A minimum of three years of supervisory / management experience is required.
• MLS (ASCP), MLT, MT or equivalent certification is highly desired
• CPR certification or ability to obtain