Cellular Specialist

Position develops processes suited for clinical and commercial manufacture of cell therapy products. Works with internal lab teams and vendor partners to ensure appropriate product line strategies and delivery of our cell and gene therapy pipeline. Maintains external marketplace knowledge and customer relationships with key business and clinical stakeholders for ongoing new business development efforts. Demonstrates a working knowledge of cellular laboratory processes and techniques, maintaining the highest level of skill and ability associated with tissue and cellular processing and maintenance;

CLIA Definitions for Supervisor and Testing Personnel:

Responsible for the following duties stipulated in 42 CFR 493.1463 and 42 CFR 493.1495, General Supervisor and Testing Personnel responsibilities.

• Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor.
• Responsible for providing day-to-day supervision of high complexity test performance by testing personnel qualified under 42 CFR 493.1489.
• Responsible for monitoring test analyses and specimen examinations to ensure acceptable levels of analytic performance are maintained.
• Assuring all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
• Ensuring patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
• Providing orientation to all testing personnel.
• Annually evaluating and documenting the performance of all testing personnel.
• Each individual performs only those moderate/high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual’s education, training or experience, and technical abilities.
• Each individual performing moderate/high complexity testing must:

a. Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient results.

b. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples.

c. Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.

d. Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.

e. Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director.

f. Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.

DUTIES AND RESPONSIBILITIES:

• Performs all steps related to cellular processing; collection, transportation, sample submission and result review, mechanical isolation, enzymatic digestion, seeding and passing of cell lines, cell harvest, and cryopreservation.
• Adheres to strict sterile technique practices and suggests appropriate process changes as necessary.
• Maintains accurate, concurrent, and complete records of all performed tasks associated with cellular processing.
• Manages inventory: ordering supplies, maintaining order records, investigating back ordered items, and monitoring expirations.
• Ensures instrumentation validation, calibration, and operational quality control, including daily, weekly, monthly tasks, and scheduling preventative maintenance with associated companies, is performed.
• Ensures regular cleaning of laboratory areas, commensurate to isolation level.
• Displays ability to choose and implement appropriate use of PPE.
• Coordinates and prepares characterization testing with LifeShare’s molecular testing laboratory, if applicable, as well as off-site testing when needed.
• Interacts with Dendreon collection team and LifeShare pheresis collection team, when necessary, for processing and/or distribution of product, coordinating necessary shipments with Hospital Services, when applicable.
• Maintains complete and accurate records and locations of frozen and cryopreserved products.
• Develops and maintains SOPs related to cellular laboratory, including upload into electronic document control.
• Participates in Quality activities, such as performing quality control testing, troubleshooting unexpected QC results, recognizing and reporting deviations from SOPs, troubleshooting equipment malfunctions, and performing proficiency testing. Assists in monitoring overall effectiveness of quality assurance programs by reporting observations and making recommendations for improvement.
• Adheres to established quality practices while seeking to continually improve work performance.
• Develops and implements training protocols and maintains all training records, including hard copy or electronic records.
• Maintains state licensure through LSBME by participating in required continuing education programs.
• Models LifeShare’s mission and values, integrating them into daily decisions, behaviors, and actions.
• Promotes cooperation and communication within a team to achieve company and departmental goals.
• Completes other tasks and duties as assigned.

CORE COMPETENCIES:

Bachelor’s degree in medical technology or related scientific field, or equivalent work experience

• MLS(ASCP) or national equivalent certification required. MLS(ASCP)SBB or other specialized MLS degree preferred
• Prior supervisory experience preferred
• Current CLP licensure, or license eligible by LA State Board of Medical Examiners
• Working knowledge of cellular laboratory testing and processes, whether within LifeShare Blood Center or from an outside laboratory
• Demonstrated working knowledge of AABB standards, CLIA and FDA regulations, OSHA requirements and current Good Manufacturing Practices (cGMP) for laboratory operations
• Proficiency in the operation and maintenance of laboratory equipment
• Ability to maintain confidentiality of patient/donor information at all times
• Ability to work effectively under stressful situations and demonstrate need to ask for help when appropriate
• Must be dependable, punctual, and have effective communication skills
• Must demonstrate a positive approach toward customers and other staff members, acting in a highly professional manner at all times

PHYSICAL DEMANDS / WORKING CONDITIONS / ENVIRONMENT:

• Work is generally performed in a laboratory setting but may include some moderately heavy lifting and clerical work
• Must be able to work fluctuating hours to accommodate receiving and processing donor tissues, as well as testing or maintenance of live cellular products; may include weekends and holidays as needed.
• Must be able to perform duties which require standing or bending for long periods of time without relief.
• Must be able to work with laboratory equipment, needles, scissors, blood bags, human blood, and collection equipment.
• Work involves potential exposure to infectious diseases from blood and blood products, and tissues.
• Must be able to maintain adequate sterility in clean areas of the laboratory, including adherence to LifeShare’s fragrance free policy.

The requirements and physical demands listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made in accordance with the ADA to enable qualified individuals with disabilities to perform the essential job functions.

Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performance by employees within this classification. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.