Senior Cellular Therapy Scientist - Cell Therapy Lab

Description

The Senior Cellular Therapy Scientist reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

Technical:

• Responsible for manufacturing of autologous and allogeneic cell and gene therapy products according to standard operating procedures, and specific guidance for clinical trials/commercial products, using aseptic technique
• Performs cell and gene therapy product manufacturing under GXP (GLP, GTP, GMP, GDP) guidelines and protocols to ensure the quality of cellular therapy products and regulatory compliance
• Performs various quality control testing of cellular therapy products and components with immunological and cell biological techniques required for the quality of cellular therapy products
• Performs cellular therapy product infusion preparation and product transport under established procedures
• Accurately document processing records, generate and review processing reports and charts
• Assist in inspections and audits to ensure compliance with regulations from Federal Drug Administration (FDA) and other regulatory agencies
• Required to wear pager to respond promptly to emergency calls and for critical equipment failure.
• Performs cell and gene therapy manufacturing process development, assay development, optimization, validation, and verification for cellular therapy investigational new drug applications
• Ability to troubleshoot issues in process and assay development, analyze results and compile reports.
• Performs technology transfer from lab bench to clinical manufacturing
• Performs preventative maintenance on facility and instruments/equipment in a timely fashion according to defined procedures and schedule
• Assists in equipment installation/operation/performance qualifications (IQ/OQ/PQ)
• Verifies reagents and supplies meet defined acceptability criteria upon receipt and prior to use; take action to ensure unacceptable items are removed from use; ensures that sufficient reagents and supplies necessary for manufacturing are available
• Performs and records all necessary quality control (QC) required for product manufacture, evaluate QC results and take necessary corrective actions according to established protocol
• Writes or assist in writing standard operating procedures
• Reviews results for completeness, correctness, and consistency
• Participate in training and competency assessment. Keep up with current knowledge of cellular therapy product manufacturing and analytical techniques and industry practices

Universal responsibilities:

• Ensures quality of operations:
  • Follows written standard operating procedures (SOP)
  • Operates instruments/equipment according to protocol
  • Uses computers according to established protocol; follows downtime procedures as required
  • Performs required quality system responsibilities
  • Participates in the training of new employees, fellows and students
  • Attends at least one personal development session per year
  • Performs other duties as assigned, or as needed, to ensure continued quality operations
• Ensures safety of operations:
  • Follows all required safety procedures, uses personal protective equipment (PPE) appropriate for tasks performed, and assumes a proactive role in laboratory safety
  • Maintains clean and organized work area
• Provides service excellence:
  • Answers telephone when needed, using NM telephone etiquette
  • Maintains patient confidentiality including protected health information (PHI)
  • Assists patients, visitors and other contacts whenever need occurs

Additional responsibilities:

• In addition to the responsibilities of a Cellular Therapy Scientist, a Senior Cellular Therapy Scientist provides technical/administrative oversight to and directs the work of personnel who may perform both routine and non-routine or specialized tests and analyses in a designated section.
• Assist department management to oversee the day-to-day operations
• Collaborate with manager in monitoring the operations of department to ensure the service standards and financial goals are met
• Coordinate the maintenance and repair activities as related to equipment and facilities
• Document maintenance and repairs of equipment and facilities and file calibration, preventive maintenance, monitoring logs, and service records as required
• Evaluate instruments and equipment systems and make recommendations for acquisition to facility management
• Establish user requirements for purchase and qualification of equipment
• Order lab equipment, parts and service requests as needed
• Prepare, maintain and coordinate the environmental monitoring schedule
• Participate in instrument computer software updates
• Review and update laboratory Chemical Inventory and submit to NM Safety Department
• Represent department at the NM Safety meetings and collaborate with the NM Safety Department on any safety issue or concern within the laboratory
• Participate in preparation and monitoring of…