Supervisor Cellular Therapy Laboratory

Versiti•Grand Rapids, MI

2d•Onsite

About The Position

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.

Requirements

Bachelor's Degree in related field required
4-6 years Cellular Therapy Processing required
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
General office equipment (desk top, lap top, tablet, printer, fax, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required
Valid driver's license required

Nice To Haves

1-3 years Continuous improvement experience preferred
CLS (MT/MLS), (ASCP) or SBB preferred

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