Overview
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
Supervises and coordinates all activities of the Cellular Therapy Laboratory in accordance with standard operating procedures. Ensures departmental and compliance requirements are maintained along with staffing and mentoring team members to ensure staff engagement and productivity.
Total Rewards Package
Compensation
The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.
Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
- Leads in selection, training, orientation, supervision, evaluation, and counseling of employees and leads daily oversight of laboratory activities.
- Develops, understands, implements, and manages Standard Operating Procedures (SOPs) and other procedures in keeping with current Good Manufacturing Practices (cGMPs)
- Maintains regulated operations in compliance with the accreditation standards and regulatory requirements (FDA, AABB, FACT, etc.)
- Reviews and signs reports, quality control records, maintains files, ensures instrument preventative maintenance and qc are performed and documented. Troubleshoots as needed.
- Participates in external and external audits, attends customer meetings as needed.
- Assists in budget development and ongoing monitoring of expenses
- Assists in development and achievement of departmental goals consistent with the mission and strategic plan
- Leads in designing/performing or optimizing processes, validations, and training protocols
- Assists in developing and introducing new testing procedures, cell processing methodologies, and technologies; re-evaluates current procedures to stay current with technology.
- Works effectively to maintain interdepartmental cooperation, develops Versiti-wide peer relationships and works effectively in functional group settings.
- Implements new clinical trial cell processing documentation, communications, and processing requirements
- Maintains competencies and performs technologists tasks of the Cellular Therapy Lab as needed due to staffing or workload
- Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
- Understands and performs in accordance with all applicable regulatory and compliance requirements
- Complies with all standard operating policies and procedures
Qualifications
Education
- Bachelor's Degree Bachelor's Degree in related field required required
Experience
- 4-6 years Cellular Therapy Processing required
- 1-3 years Continuous improvement experience preferred
Knowledge, Skills and Abilities
- Extensive knowledge of current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) regulations, Association for the Advancement of Blood and Biotherapies, and International Organization of Standardization (ISO) requirements required
- Understanding of process improvement techniques: root cause analysis, critical thinking and problem solving skills required
- Ability to work independently required
- Ability to partner with all levels of the organization and external customers required
- Excellent oral and written communication skills to include technical writing and design-effective reporting required
- Project planning skills necessary to oversee, manage, and complete projects within deadlines required
- Thorough understanding of the validation and change control process and the ability to train others in this area required
Licenses and Certifications
- CLS (MT/MLS), (ASCP) or SBB preferred
Tools and Technology
- General office equipment (desk top, lap top, tablet, printer, fax, copy machine) required
- Microsoft Suite (Word, Excel, PowerPoint) required
- Valid driver's license required
