Position Title:  Senior Technical Laboratory Specialist

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Are you seeking daily adventure while advancing your career? Look no further.

Reporting to the Director of Laboratory Services, the Senior Technical Lab Specialist drives the launch of high-complexity testing services, ensures compliance with FDA, AABB, CLIA, CAP, USP, GxP and USP standards, and collaborates cross-functionally to translate client and business needs into effective laboratory solutions. The position also supports operational excellence through quality oversight, equipment management, SOP development, performance analytics, audit readiness, and continuous improvement initiatives to maintain scalable, compliant, and high-quality laboratory services.

Just For You:

• Medical Center location with Free Parking.

• Career advancement.

• Engaging and exciting opportunity to SAVE LIVES.
  

Tips to thrive in our culture:

• Embody our Core Values of Commitment, Integrity, and Respect

• Work to actively create experiences that inspire others to save lives, each and every day.

• Embrace doing it right, making connections, and creating desired experiences.

• Comply with all organizational policies and standards, including safety rules, and be willing to report actual and potential violations to the appropriate supervisor or manager.

In this role, you will:

Development & Operational Launch of High-Complexity Tests – 30%

• Spearhead the development, validation, and operational implementation of new high-complexity testing services supporting product quality control, new product lines and expansion of cellular therapy offerings.

• Lead cross-functional project planning from feasibility assessment through operational launch.

• Coordinate with Quality, Regulatory, and Operations teams to ensure compliance with applicable standards (e.g., FDA, AABB, CLIA, CAP, GxP and USP as applicable).

• Provide technical leadership during test transfers, scale-up, and post-launch performance monitoring.

Assay Design & Product Characterization – 20%

• Design, optimize, and validate flow cytometry–based assays for product cell marker characterization.

• Develop gating strategies, panel design, and analytical workflows to ensure accurate and reproducible product profiling.

• Establish assay performance characteristics including accuracy, precision, specificity, sensitivity, and robustness.

• Generate technical documentation, validation protocols, and summary reports to support regulatory and client requirements.

Client & Business Development Collaboration – 20%

• Partner with Business Development and Management to evaluate technical feasibility of new testing requests.

• Communicate directly with potential clients to understand scientific, regulatory, and timeline requirements.

• Translate client needs into assay development plans, resource estimates, and implementation strategies.

• Provide subject matter expertise in proposal development and client presentations.

Department Operations Support – 20%

• Develop and generate operational reports, metrics dashboards, and data analytics to support department performance monitoring and strategic decision-making.

• Monitor and provide oversight of equipment maintenance, calibration, and service schedules to ensure operational readiness and compliance.

• Oversee quality control processes, review QC trends, and implement corrective actions as needed.

• Troubleshoot and resolve complex technical issues related to assays, instrumentation, and laboratory workflows.

• Author, revise, and maintain Standard Operating Procedures (SOPs), validation protocols, and supporting technical documentation.

• Lead or participate in Corrective and Preventive Action (CAPA) activities, quality investigations, and continuous quality improvement initiatives.

• Contribute to quality reporting, audit readiness, and regulatory inspection preparation.

Technical Evaluation and Innovation – 10%

• Research testing methodologies, instrumentation, and technologies to support evolving business and client needs.

• Evaluate equipment options, conduct cost analyses, and compare vendor proposals for new or replacement test systems.

• Assist in development of business cases and technical recommendations for management regarding upgrades, innovation initiatives, and capital investments.

• Continuously assess and improve existing testing platforms to enhance efficiency, quality, and scalability.

• Additional duties as assigned. 
  

We need someone who has:

• Bachelor’s degree in a clinical or life science-related field from an accredited college or university

• Eight plus years high complexity testing leadership experience within a cellular therapy, pharmaceutical, or therapeutic research laboratory environment.

• Minimum four plus years experience in flow cytometry, PCR, Endotoxin or mycoplasma testing.

• Prior experience supporting start-up laboratories is highly preferred.

• Strong regulatory knowledge in United States Pharmacopeia (USP) regulations required.
  

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch or crawl and talk and hear.  The employee frequently is required to stand and walk; occasionally required to sit, climb or balance.  The employee must frequently lift and/or move up to 25 lbs. Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program in an effort to prevent bodily injury and for the health and safety of others.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to blood and blood components as well as other biohazard materials, moving mechanical parts and extreme cold.  The employee is occasionally exposed to toxic or caustic chemicals, risk of electrical shock, and risk of radiation.  The noise level in the work environment is usually moderate.

Job duties involve an inherent potential for mucous membrane or skin contact with blood with a risk of exposure to Hepatitis and HIV.

Who We Are:

Since 1975, Gulf Coast Blood has been one of the nation’s largest community blood centers, serving 170 hospitals across 26 counties. Headquartered in Houston, we support the world’s largest medical complex—the Texas Medical Center—while operating 18 donor centers and hosting more than 7,000 mobile blood drives each year. As an FDA-accredited nonprofit, we provide high-quality human cellular material for both scientific and therapeutic use.

Some Jobs Change Lives. Others Save Them. 

Think you have what it takes to save lives with us? We want to hear from you.

EQUAL OPPORTUNITY EMPLOYER STATEMENT

Gulf Coast Blood is an Equal Employment Opportunity Employer. Qualified applicants for positions are considered without regard to race/ethnicity, color, religion, national origin, age, pregnancy, sex, sexual orientation, gender identity, transgender status, military status, protected veteran status, disability status, genetic testing results, or any other basis or characteristic prohibited by applicable law, statute, regulation or Executive Order.