Description

Immunologic Monitoring and Cellular Production Laboratory (IMCPL) is the centralized academic laboratory conducting cGMP cellular therapy manufacturing and diagnostic testing. With over 20,000 ft² (two laboratories at Shadyside and Riviera locations), IMCPL is the largest cellular therapy operation in the southwestern Pennsylvania region, currently staffed by a medical/laboratory director, 2 quality assurance staff, and 25+ full-time personnel. IMCPL is a FDA registered, Pennsylvania state/CLIA certified, College of American Pathologists (CAP) accredited and Foundation for the Accreditation of Cellular Therapy (FACT) accredited laboratory. IMCPL provides critical laboratory support for various commercial as well as investigative cellular therapy product manufacturing and handling, such as Chimeric Antigen Receptor T (CAR-T) cells, tumor infiltrating lymphocytes (TIL), various dendritic cells, hematopoietic progenitor cells, donor T lymphocytes, and peptide-based vaccines. It currents supports all FDA-approved Chimeric Antigen Receptor T (CAR-T) cells for hematologic malignancies and 10+ IND-based CAR-T clinical trials. Currently, IMCPL manufactures multiple active cell-based and biologic INDs for clinical trials. The immunologic monitoring laboratory supports 35+ clinical trials for clinical patient blood processing and provide various assay testing. IMCPL directly receives Cancer Center Support Grant (CCSG) by providing critical laboratory services to UPMC Hillman Cancer Center, an NCI designated comprehensive cancer center. IMCPL has also recently developed contract development and manufacturing organization (CDMO) for various industry/commercial partners at Pittsburgh and beyond. 

The IMCPL director of operation (posted position) will be directly reporting to the overall medical/laboratory director of IMCPL. The qualified candidate will be responsible for strategic decision-making, policy development, and policy implementation for IMCPL. Accountable for the operation's performance (service, quality, and financial) for IMCPLs two locations: Hillman Shadyside & Riviera. Ensure compliance with all state, federal and regulatory agencies. Coordinate research studies and cell production with outside institutions using the facility's resources. Create and manage the operating and capital budgets.

Responsibilities:

• Oversight of daily activities of operation for two (2) locations; IMCPL Shadyside & IMCPL Riviera.
• Create and implement IMCPL program development plans that support and advance the BU and hospital strategic initiatives. Assist faculty and coach staff to establish and achieve programmatic goals.
• Plan, organize, conduct and document testing programs for IMCPL. Plan, organize and conduct investigation/deviation reports as required by FDA.
• Prepare budgetary, billing submission and reconciliation for IMCPL.
• Manage the human resources functions for IMCPL including recruitment, training and competency evaluations, performance reviews, and corrective action regarding staff within IMCPL.
• Review QC data, technical reports, equipment records and other data received by the laboratory or generated by the staff. Assist to establish and implement cGMP systems and documentation in the Quality Control, Validation and Cellular Production. Assist in completing INDs for cell therapy products.
• Create a culture of service excellence focused on defining, understanding and consistently satisfying the requirements of both internal and external customers.
• Implement, monitor and evaluate all quality initiatives to ensure positive outcomes.
• Oversee all contracts and grants for IMCPL. Provide direction and support to the IMCPL management staff for clinical purchasing (pharmaceuticals, laboratory supplies, med-surgical supplies, equipment, etc.) Work with Facilities and Materials Management and appropriate vendors to ensure that practices are provided with cost-effective and high quality products and supplies. May act as liaison to outside vendors.
• Serve on all committees as assigned. Provide leadership, oversight and direction for assigned special project activities.
• *Performs in accordance with system-wide competencies/behaviors.*Performs other duties as assigned.

Qualifications

• Bachelor's Degree in Health Care Administration, Business Administration, Finance, Accounting, Biology/Immunology/Human Genetics or related field  and 15 years of experience 
• Experience in cell therapy preferred and/or quality assurance preferred.
• Knowledge of revenue cycle, physician billing, and contracts, preferred.

OR

• Master's Degree in Health Care Administration, Business Administration, Finance, Accounting, Biology/Immunology/Human Genetics or related field / 10 years of experience
• Experience in cell therapy preferred and/or quality assurance preferred.
• Knowledge of revenue cycle, physician billing, and contracts, preferred.

OR

• PhD Degree in Health Care Administration, Business Administration, Finance, Accounting, Biology/Immunology/Human Genetics or related field / 4 years of experience.
• Experience in cell therapy preferred and/or quality assurance preferred.
• Knowledge of revenue cycle, physician billing, and contracts, preferred.

Licensure, Certifications, and Clearances:

• Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran

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