Clinical Laboratory Manager

BioLegend, Inc.; Hebron Estates (KY); Presencial; USD 112.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, and Vision Insurance

Life and Disability Insurance

Paid Time-Off

Parental Benefits

Compassionate Care Leave

401k with Company Match

Employee Stock Purchase Plan

Descripción de la vacante

Revvity’s ViaCord unit seeks a Clinical Laboratory Manager to lead the cord blood/cord tissue processing lab. You will supervise technologists, ensure regulatory compliance, and drive process improvements across testing, cryopreservation, and storage.

The role requires strong expertise in flow cytometry, hemacytometry, blood typing, and molecular testing, with a track record of managing validated methods and SOPs.

Formación

• Bachelor's or Master’s degree in a life science field or medical technology.
• 10+ years in regulated lab operations with cellular therapy/cord blood.
• 5+ years leading laboratory teams and ensuring compliance.

Responsabilidades

• Oversee cord blood/cord tissue processing, testing, cryopreservation, and release.
• Direct supervision, training, and performance management of lab staff.
• Ensure accuracy of data, batch records, and regulatory documentation.

Conocimientos

Leadership

Regulatory compliance

Flow cytometry

Hemacytometry

Cell counting

Molecular testing

Educación

Bachelor's degree in Medical Technology/Clinical Laboratory Science

Master's degree in Medical Technology/Clinical Laboratory Science

Herramientas

Hemacytometer

Flow cytometer

Descripción del empleo

ViaCord from Revvity is seeking a highly motivated and experienced Clinical Laboratory Manager to provide operational and technical leadership for its cellular therapy laboratory. This full-time position is responsible for the daily management and supervision of cord blood and cord tissue processing, characterization, cryopreservation, and storage activities, while ensuring compliance with all applicable regulatory and accreditation requirements.

Key Responsibilities

• Oversee daily laboratory operations related to cord blood and cord tissue processing, testing, cryopreservation, and release activities.
• Direct and supervise laboratory technologists, providing leadership, training, performance management, and professional development.
• Ensure accurate characterization of cellular products utilizing flow cytometry, hemacytometry, blood typing, and molecular testing methodologies.
• Review and approve laboratory data, test results, batch records, and associated documentation to ensure accuracy, completeness, and regulatory compliance.
• Provide technical expertise and troubleshooting support for laboratory processes, equipment, assays, and workflow challenges.
• Lead method validations, process qualifications, and implementation of new technologies and procedures.
• Develop, revise, and maintain standard operating procedures (SOPs), work instructions, and technical documentation.
• Monitor laboratory key performance indicators (KPIs), operational metrics, and quality indicators to drive continuous improvement initiatives.
• Investigate deviations, nonconformances, and quality events, and communicate findings and corrective actions to Laboratory Leadership and Quality Management.
• Partner with Quality Assurance to support audits, inspections, corrective and preventive actions (CAPAs), and regulatory submissions as required.
• Ensure adherence to all applicable laboratory safety, quality, and regulatory standards.

Required Qualifications

• Bachelor's degree in Medical Technology, Clinical Laboratory Science, Biology, Biotechnology, or any life science discipline.
• 5+ years of experience managing laboratory operations within a regulated environment.
  • Operating and maintaining compliance with regulatory and accreditation requirements including the U.S. Food and Drug Administration (FDA) regulations, American Association of Blood Banks (AABB) Standards, Clinical Laboratory Improvement Amendments (CLIA), Current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP) requirements.
• 10+ years of experience working in a laboratory using cellular therapy, cord blood banking, tissue processing, and/or cryopreservation practices.
• 10+ years of experience with flow cytometry, manual and automated cell counting techniques, blood typing, and molecular laboratory methods.

OR

• Master's degree in Medical Technology, Clinical Laboratory Science, Biology, Biotechnology, or any life science discipline.
• 3+ years experience managing laboratory operations within a regulated environment.
  • Operating and maintaining compliance with regulatory and accreditation requirements including the U.S. Food and Drug Administration (FDA) regulations, American Association of Blood Banks (AABB) Standards, Clinical Laboratory Improvement Amendments (CLIA), Current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP) requirements.
• 5+ years experience working in a laboratory using cellular therapy, cord blood banking, tissue processing, and/or cryopreservation practices.
• 5+ years experience with flow cytometry, manual and automated cell counting techniques, blood typing, and molecular laboratory methods.

Preferred Qualifications

• Proven ability to lead technical staff, manage laboratory performance, and drive operational excellence.
• Excellent written and verbal communication skills, with experience developing technical procedures and presenting performance and quality data.

Compensation Range:

The annual base salary range for this full-time position is $112,000 - 150,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

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What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.

For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.