Clinical Laboratory Manager

Revvity, Inc.; Hebron Estates (KY); On-site; USD 112,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Life and Disability Insurance

Paid Time Off

Parental Benefits

Compassionate Care Leave

401k with Company Match

Employee Stock Purchase Plan

Job summary

Revvity, Inc. via ViaCord seeks a Clinical Laboratory Manager to provide operational and technical leadership for its cord blood and cord tissue laboratory in Kentucky. You will supervise technologists, ensure regulatory compliance, and oversee processing, testing, and cryopreservation activities.

The role requires extensive experience in cellular therapy, flow cytometry, and SOP development, with a focus on quality and continuous improvement within a regulated environment.

Qualifications

• Bachelor's or Master’s degree in a life science discipline with CLIA/regulatory exposure.
• 10+ years in cellular therapy, cord blood/tissue processing, or cryopreservation.
• 5+ years in regulated lab operations management; 10+ years in flow cytometry and cell counting.

Responsibilities

• Oversee cord blood/tissue processing, testing, cryopreservation, and release activities.
• Lead and develop laboratory staff; manage performance and training.
• Ensure data accuracy, review batch records and regulatory documentation.
• Provide technical troubleshooting and lead new method implementations.
• Develop and maintain SOPs, work instructions, and quality docs.
• Monitor KPIs and quality indicators to drive improvement.
• Coordinate with QA for audits, CAPAs, and regulatory submissions.
• Maintain compliance with FDA, AABB, CLIA, cGTP and cGMP standards.
• Ensure laboratory safety and regulatory adherence.

Skills

Laboratory management

Flow cytometry

Regulatory compliance

Leadership

Documentation

Education

Bachelor's degree in Medical Technology / Clinical Laboratory Science

Master's degree in Medical Technology / Clinical Laboratory Science

Job description

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.

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.