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Highmark Health Cellular Therapy Specialist in Pittsburgh, Pennsylvania

Company :

Allegheny Health Network

Job Description :

GENERAL OVERVIEW:

This job is responsible for a variety of highly complex procedures required for the collection, storage, processing, genetic modification and transplantation of human stem cell and immune effector cell products.

ESSENTIAL RESPONSIBILITIES:

  • Performs patient-facing procedures, including therapeutic apheresis procedures, such as plasma exchange, extracorporeal photopheresis, etc. as well as peripheral blood stem cell collection, peripheral blood mononuclear cell collection, autologous and allogeneic stem cell product infusion and infusion of immune effector cells (25%).

  • Performs specialized laboratory procedures, including processing of cellular therapy products, processing of patient specimens and the manufacture of genetically modified and unmodified immune effector cell products. Receives and distributes cellular therapy products according to standard operating procedures (15).

  • Performs specialized laboratory procedures, required for quality control and release criteria testing of cellular therapy products. Maintains an understanding of statistical techniques required for quality control methods (10%).

  • Participates in a call schedule providing 24-hour coverage for all procedures and equipment failure (10%).

  • Participates as an integral member of the multi-disciplinary team that plans, collects, processes, manufactures and distributes cellular therapy products (10%).

  • Maintains competence in laboratory standard operating procedures (SOP) and initiates changes to these procedures as needed and according to established laboratory oversight.Pursues continuing education in Cellular Therapy. Readily shares knowledge and experience with other health care providers (10%).

  • Compliant with relevant regulatory agencies such as the Food and Drug Administration (FDA) and accrediting bodies such as the Foundation for the Accreditation of Cellular Therapy (FACT) and the College of American Pathologists (CAP) as it pertains to the scope of services offered by the laboratory. Knowledge of Good Tissue Practice (cGTP) and Good Manufacturing Practice (cGMP) (10%)..

  • Performs key clinical trial functions for all trials involving cellular therapy products (10%)..

  • Other duties as assigned or requested.

QUALIFICATIONS:

Minimum

  • Bachelor's degree in Life Science or 5 years of relevant experience and/or education as determined by the company in lieu of bachelor's degree.

Preferred

  • None

EXPERIENCE:

Minimum:

  • None

Preferred:

  • Experience in Stem Cell Processing and/or Blood Banking

SKILLS:

  • Able to work independently with minimal supervision with established SOPs

  • Able to adjust to on call schedule

  • Competent to work with computers (Microsoft Word, Excel, etc.)

  • Able to perform complex mathematical calculations

  • Communicate effectively and professionally with other lab staff and health care professionals

LICENSES or CERTIFICATION:

Minimum:

  • None

Preferred:

  • American Society of Clinical Pathologists Board of Certifications (ASCP BOC)

Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.

Compliance Requirement : This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.

As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy.

Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, age, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, age, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability.

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For accommodation requests, please contact HR Services Online at HRServices@highmarkhealth.org

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Req ID: J255013

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