Laboratory Manager

KEDPLASMA; New York (NY); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Retirement plans

Paid time off

Training programs

Employee discounts

Job summary

KEDPLASMA, a Kedrion Biopharma Inc. subsidiary, seeks a Laboratory Manager to lead daily operations of our plasma testing laboratory in New York.

You will ensure regulatory compliance, testing accuracy, and high-quality outcomes across specialty plasma programs, while guiding a team and coordinating with cross-functional units. The role emphasizes SOP development, data integrity, vendor coordination, and ongoing method validation to meet evolving customer and regulatory needs; a strong

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• ASCP certification or equivalent national certification preferred.
• Licensed CLS across relevant specialties preferred.
• 5–10 years in hospital laboratory, plasma, or blood collection environment preferred.
• Knowledge of FDA cGMP, CLIA, and OSHA standards.

Responsibilities

• Oversee daily laboratory operations, testing specialty plasma samples with regulatory compliance.
• Create, update SOPs aligned with QMS for consistent lab processes.
• Coordinate testing activities including sample processing, instrument calibration, maintenance, and QC/QA.
• Monitor and validate test results for accuracy and reliability.
• Manage inventory, supplies, and reagents to ensure uninterrupted operations.
• Lead and develop laboratory staff, including hiring, training, and performance management.

Skills

Leadership

Quality control

Regulatory compliance

Laboratory operations

Data management

SOP development

Education

Bachelor's degree in Life Sciences

Job description

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.

Job Summary

Lead the science behind life-saving therapies as a Laboratory Manager. In this role, you will oversee daily laboratory operations supporting specialty plasma programs, ensuring accurate testing, regulatory compliance, and high-quality outcomes. You will play a critical role in maintaining laboratory performance, advancing testing capabilities, and delivering results that meet strict industry standards while supporting organizational goals and customer requirements.

What You'll Do

• Oversee daily laboratory operations, including testing specialty plasma samples, ensuring accuracy, efficiency, and compliance with regulatory standards such as FDA cGMP, CLIA, and OSHA requirements
• Create, update, and enforce Standard Operating Procedures (SOPs) aligned with the Quality Management System (QMS) to ensure consistent execution of laboratory processes
• Coordinate laboratory testing activities including sample processing, test execution, instrument calibration, maintenance, troubleshooting, and quality control/assurance
• Monitor and validate laboratory test results, ensuring accuracy and reliability across all testing activities
• Manage laboratory inventory, ordering supplies, reagents, and consumables required for uninterrupted operations
• Calculate and evaluate quality control metrics, including standard deviations and calibration standards, to ensure proper test performance
• Oversee outsourced testing processes, including coordinating sample logistics and communication with external laboratories
• Maintain accurate data entry, donor records, and testing documentation, ensuring proper tracking and compliance with program requirements
• Manage specialty program inventory and collaborate with Supply Chain, Quality, and operational teams to ensure appropriate stock levels and customer fulfillment
• Configure and prepare customer sample pools to meet volume and potency specifications, and coordinate shipment execution
• Implement and validate new testing methods, instruments, and procedures to meet evolving customer and regulatory requirements
• Schedule and maintain laboratory equipment, including preventative maintenance, calibration, and validation documentation
• Support internal and external audits by providing required documentation and driving corrective actions where needed
• Communicate effectively with vendors, technical support teams, and customer representatives to resolve issues and maintain service standards
• Oversee licensing requirements and support renewal processes to maintain operational compliance
• Lead, develop, and manage laboratory staff, including hiring, training, coaching, performance management, and workload distribution
• Foster a positive, collaborative, and performance-driven work environment that supports employee engagement and retention

Qualifications And Need-to-know

• Bachelor’s degree in Life Sciences or a related field required
• ASCP certification or equivalent national certification required
• Licensed Clinical Laboratory Supervisor across relevant specialties preferred
• 5–10 years of experience in a hospital laboratory, plasma, or blood collection environment preferred
• Knowledge of laboratory testing protocols and viral marker testing preferred
• Strong understanding of regulatory requirements including FDA cGMP, CLIA, and OSHA standards
• Demonstrated experience managing laboratory operations, including quality control, equipment maintenance, and testing procedures
• Proven leadership experience with the ability to manage, coach, and develop team members
• Experience with laboratory data management and documentation processes
• Ability to implement new procedures, validate methods, and adapt to evolving operational requirements

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary ranges are determined based on relevant experience, education, and certifications.

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at [e-mail].

Employee Benefits:

• Health & Wellness – Full medical, dental, and vision coverage
• Financial Security – Life insurance, AD&D, and retirement savings plans
• Work-Life Balance – Paid time off, sick leave, and paid holidays
• Career Growth – Training programs and development opportunities
• Extra Perks – Employee discounts, wellness initiatives, and more!

For specific inquiries please reach out to us

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.