Job Summary

The CLS Manager, Clinical Laboratory is primarily responsible for working directly with senior manufacturing leadership to support the productivity and day-to-day operations of the Clinical Laboratory towards manufacturing of blood-based products.  The successful candidate is also the lead for clinical Regulatory compliance (CLIA, CAP, etc) in concert with the senior medical leadership.

Essential Responsibilities:

• Oversees, supervises, and mentors work of laboratory technicians/CLS’s to ensure staff complies with SOP and GMP practices.  Provides routine performance feedback to team members, manages performance issues, and works with Scientific Director to conduct performance reviews.
• Oversees the development, implementation, and maintenance of appropriate staff training program.  Prepares, performs, and reports proficiency testing (ie. CAP).  Assesses the department capacity relative to existing and projected product needs and proposes additional staff as needed to avoid service failures.
• Presents a professional image to customers, both internal and external. Acts as a role model for the laboratory.
• Completes all documents and results needed for GMP Collection packets.  Reviews/approves MBR and final packet for disposition.  Performs the daily lab review of test results. Reviews and approves error/accident reports, all related root cause analysis, corrective actions, preventive action, and follow-up, as applicable.
• Designs, formalizes, and executes experiments to meet strategic marketing objectives for the organization.  Plans, organizes, and leads projects to improve efficiency and productivity.  Evaluates and provide purchasing recommendations for lab equipment, reagents, and supplies.
• Identifies and troubleshoots problems encountered in assigned tasks and properly document corrective actions.  Confers with managerial staff for problem resolutions, if necessary.
• Reviews and provides all the materials, binders and documents needed for Internal Audits and Inspections performed by AABB, FDA, and State.
• Supports management to develop budget and resources for the general laboratory department.  Reviews, orders, and maintains proper inventory levels of laboratory supplies/reagents.
• Performs fresh leukopak processing, separation, and labeling (manufacturing) as needed.  Accurately performs testing of blood products and donor samples (eg., hematology counts (CBC)). Accurately records, interprets, reviews and reports test results.  Able to recognize and appropriately handle unacceptable test results.  Performs quarantine, destruction, and release of blood products.
• Maintains, certifies, and validates equipment performance by establishing quality standards, developing operations, troubleshooting procedures, and arrangement of service.
• Properly performs and completes comprehension of quality control (QC) and preventative maintenance of laboratory equipment.
• Performs all tasks in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and other regulatory requirements. Participates in the development, management, review, and implementation of SOPs, policies, and procedures for existing and future operations to enhance service quality and efficiency.
• Uses blood product information system (e.g., El Dorado, DigiTrax, etc.), as well as authorizes and performs system overrides as needed/applicable.
• Performs cross training with other labs/testing assays, as applicable.

Job Qualifications

• BS/BA in Life Science, or related field; MS in Life Science is a plus.
• Must have a minimum of 5 years’ laboratory experience in a related field or equivalent industry; specific experience with cGMP or GLP a plus.  Blood donor center or transfusion service experience a plus.
• Managerial or supervisory experience in a related field or equivalent industry preferred
• Current CA state CLS licensure is required for this position
• Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
• Able to use/maintain medical and scientific lab equipment performance.

Compensation Data

The pay range for this position is $138,300 – $152,900. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.