Palo Alto, CA, 94301, USA
17 hours ago
Supervisor , Cell Pharmacy Operations
If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of America) The Supervisor for Cell Pharmacy Operation is responsible for managing daily Cell Pharmacy operations within the Stanford BMT-Cellular Therapy Facility operated by the Blood & Marrow Transplant Program and providing technical supervision as necessary. Duties include but are not limited to coordinating the daily work assignments of the CTF Cell Pharmacists including night and weekend assignments. The supervisor maintains current knowledge of regulatory requirements pertaining to the processing, storage and disposition of cellular therapy products in accordance with GTP and GMP requirements. In addition, the supervisor is responsible for the training of all subordinates in the facility’s current policies and procedures, and assesses staff proficiency and compliance with current cell processing activities, quality control assays, and regulatory requirements used in the CTF. The technical supervisor interacts frequently with the physicians, administrators and staff of the Blood and Marrow Transplantation Program, Stanford Health Care, and Stanford Children's Health in order to coordinate the scheduling of cellular product collection processing, outbound and inbound shipments and release for infusion of investigative products. Although this is primarily a day-shift position, the supervisor must be accessible to CTF staff for consultation either on-site, by telephone, or by electronic means as needed. Participates in assessment and implementation of cell-based therapies and methodologies consistent with the facility's role **A Brief Overview** Manages daily Cell Pharmacy operations within the Stanford BMT-Cellular Therapy Facility provides technical supervision as necessary. Coordinates daily work assignments of the CTF Cell Pharmacists. Maintains current knowledge of regulatory requirements pertaining to the processing, storage and disposition of cellular therapy products in accordance with GTP and GMP requirements. Responsible for the training of all subordinates in the facility's current policies and procedures, and assesses staff proficiency and compliance with current cell processing activities, quality control assays, and regulatory requirements used in the CTF. Interacts frequently with the physicians, administrators and staff of the Blood and Marrow Transplantation Program, Stanford Health Care, and Stanford Children's Health in order to coordinate the scheduling of cellular product collection processing, outbound and inbound shipments and release for infusion of investigative products. **What you will do** + Supervises daily operations of the CTF technical employees as well as the support functions provided by the Laboratory and Office Assistants. Provides oversight and instruction to individual employees on both work and administrative matters. Participates in the hiring, promotion or reassignment of subordinates; resolves employee complaints or refers them to the level at which the complaints can be resolved; recommends disciplinary measures including warnings, reprimands and suspensions; and identifies developmental needs and coordinates the appropriate training. + Provides technical expertise in cell processing and cell pharmacy procedures by maintaining current knowledge of the technical and regulatory aspects of cellular therapy processing in accordance with GTP and GMP as appropriate. + Establishes daily work schedules to ensure that all cell pharmacy processing, shipments, cryopreservation, storage, cell infusions, and quality control procedures are accomplished in a timely manner in adherence to approved SOPs and investigational study sponsor-provided procedures, where appropriate, and regulatory requirements; the Cell Pharmacy storage bank is organized, maintained and documented as per regulatory requirements and shipments and associated logistics between SHC/LPCH and third party manufacturer are coordinated. + Ensures assignment schedules are prioritized in accordance with patient and product requirements and assignments result in an equitable distribution of the work load allowing each Cell Pharmacist to frequently perform all cell pharmacy related procedures. + Ensures Cell Pharmacy is maintained in a state of operational readiness in accordance with approved policies and procedures. + Maintains standard operating procedures (SOPs) for all operations for compliance with current Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP), as appropriate, and participates in the review and revision of SOPs annually in order to meet current standards of operation for cell processing laboratories as defined by relevant accrediting and regulatory agencies. + Communicates procedural deviations, errors, and unexpected events to the laboratory director and to the quality personnel in a timely manner. + Oversees the validation and implementation of Cell Pharmacy procedures and test methods, as directed. + Communicates and collaborates with hospital and university staff, vendor representatives, and outside contractors, as necessary, to assure operational readiness of the cell pharmacy facility and completion of assigned duties. + Actively manages team activities and resource plans related to the implementation of Cell Pharmacy activities to support the onboarding and implementation of multiple simultaneous investigational studies. + Trains new personnel and assesses existing personnel in CTF policies and procedures with supporting documentation of competency in each aspect of training and updates the knowledge of the CTF Cell Pharmacy staff regarding changes in methodologies, policies, and procedures. + Participates in the recruitment, interviewing and selection of new laboratory personnel and makes recommendations regarding the subordinate promotions and disciplinary measures. + Provides back-up and support for Cell Pharmacy activities as workload and staffing demands including sharing the on-call duties for after-hours and weekend processing. + Developments and implements Cell Pharmacy procedures and test methods.. + Assesses equipment, supply and space requirements for Cell Pharmacy operations and recommends purchase of equipment, supplies, and services needed to meet cell processing objectives. + Oversees both routine and unscheduled maintenance of equipment, housekeeping and environmental monitoring. + Assists with Cell Pharmacy staff performance evaluations by observing employee bench work, staff interactions, and thoroughness in meeting QA-QC objectives and communicating regularly with the facility director regarding personnel issues. + Assures that all Cell Pharmacy staff, lab and office assistants are in compliance with applicable personal safety guidelines. **Qualifications** + Bachelor's degree in medical technology, life science, or related scientific area. + 3 years of experience in Hematology, Immunology, and/or Blood Banking and one (1) year of cell processing and/or cryopreservation experience OR four (4) years of cell therapy processing/cryopreservation experience or equivalent. + 1 year of lead tech/senior tech/supervisor/manager experience, Preferred + **Preferred to have one of the following:** CLS, ASQ (American Society of Quality) certification, or Lean Six Sigma Certification **Required Knowledge, Skills and Abilities** + Demonstrated ability to supervise a team of staff in a fast paced and ever changing environment. + Ability to follow complex written and oral instructions. + Ability to speak and write effectively at a level appropriate for the job. + Demonstrated ability to learn and use multiple computer systems and software used in functional area. + Demonstrated experience operating in multitasking environment and overseeing logistics in + Ability to perform detailed work on a consistent basis + Ability to communicate effectively with a high skill level + Ability to plan, organize and prioritize their own work and the team, work independently and meet deadlines + Ability to work effectively with individuals at all levels of the organization + Ability to perform and oversee clinical testing, including both machine and manual assays of blood/cell therapy products for patient care purposes. + Ability to independently identify and understand problems/issues of a complex nature and drive to resolution in a fast paced and high pressure environment. + Ability to interpret and synthesize results from a wide variety of tests correctly and quickly. + Ability to perform mathematical calculations and complete detailed documentation with accuracy. + Ability to fulfill continuing education requirements and demonstrate proficiencies related to cell processing and commensurate with assigned duties. + Demonstrated Knowledge of Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and/or Good Manufacturing Practices (GMP) as applied to cellular therapeutics. + Demonstrated knowledge of in Hematology, Immunology, Blood Banking and/or Cell Therapy Processing, including processing and/or cryopreservation concepts and practices. + Knowledge of Medical Terminology. **Physical Demands and Work Conditions** **Working Environment** + Frequent Working with biohazards such as blood borne pathogens, hospital waste, etc.. **Blood Borne Pathogens** + Category I - Tasks that involve exposure to blood, body fluids, or tissues **These principles apply to ALL employees:** **SHC Commitment to Providing an Exceptional Patient & Family Experience** _Stanford Health Care sets a high standard for delivering value and an exceptional experience for our patients and families. Candidates for employment and existing employees must adopt and execute C-I-CARE standards for all of patients, families and towards each other. C-I-CARE is the foundation of Stanford’s patient-experience and represents a framework for patient-centered interactions. Simply put, we do what it takes to enable and empower patients and families to focus on health, healing and recovery._ _You will do this by executing against our three experience pillars, from the patient and family’s perspective:_ + Know Me: Anticipate my needs and status to deliver effective care + Show Me the Way: Guide and prompt my actions to arrive at better outcomes and better health + Coordinate for Me: Own the complexity of my care through coordination \#LI-BS1 **Equal Opportunity Employer Stanford Health Care (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination in** **all of** **its policies and practices, including the area of employment. Accordingly, SHC does not discriminate against any person on the basis of race, color, sex, sexual orientation or gender identity and/or expression, religion, age, national or ethnic origin, political beliefs, marital status, medical condition, genetic information, veteran status, or disability, or the perception of any of the above. People of all genders, members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. Qualified applicants with criminal convictions will be considered after an individualized assessment of the conviction and the job requirements.** Base Pay Scale: Generally starting at $59.21 - $78.43 per hour The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training. This pay scale is not a promise of a particular wage. At Stanford Health Care, we seek to provide patients with the very best in diagnosis and treatment, with outstanding quality, compassion and coordination. With an unmatched track record of scientific discovery, technological innovation and translational medicine, Stanford Medicine physicians are pioneering leading edge therapies today that will change the way health care is delivered tomorrow. As part of our spirit of discovery, we also leverage our deep relationships with luminary Silicon Valley companies to develop new ways to deliver preeminent patient care. Learn about our awards (https://stanfordhealthcare.org/about-us/awards.html) and significant events (https://stanfordhealthcare.org/about-us/our-history.html) .
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