The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Clinical Manufacturing Scientist (PDM3) to provide highly specialized technical research, support and expert consultation including identifying, innovating, and designing solutions for unique activities related to clinical cell and gene therapy manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.
Manufacturing Duties include:
- Lead CCT (Center for Cancer Cell Therapy) human clinical materials biomanufacturing campaigns primarily as a verifier. Prepare final formulated cellular products for cancer therapy clinical trials within production timelines and manufacturing schedules. Mainly focused on CART and TCR based therapies.
- Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager.
- Develop methods for, perform, and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2), cGMP-level work conditions and adherence to corresponding requirements.
- Develop standard operating procedures (SOPs), Batch Records, and product specifications. Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity. Present data to functional manager and collaborative groups to support product and process specification.
- Train and supervise Manufacturing Associates and Specialists. May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedules and constraints.
- May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- Author or co-author of manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences.
- Participate in discussions with internal and external collaborators, providing analyzed data and review when appropriate.
- Participate in discussions with CCT Process Development and Manufacturing teams, providing analyzed data and feedback when appropriate.
- Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
- May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.
The Center for Cancer Cell Therapy is a part of the Stanford Cancer Institute (SCI), which is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.
*- Other duties may also be assigned
- Bachelor's degree in chemistry, microbiology, biological sciences, etc. with 4 years of experience. Or Master’s degree in related field with 2 years of experience
- Aseptic technique and cell culture experience is preferred
- cGMP experience is preferred.
- Previous supervisory or management experience is desired.
- Experience with CAR T, TCR, T cells, gene editing, and cell and gene therapy process development/manufacturing desired.
- Knowledge of and experience generating SOPs, batch records, and other documentation for clinical manufacturing of cell and gene therapy products is preferred
- Experience with tech transfer, engineering/qualification runs a plus
- Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules
- Experience with following assays a plus: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR
- Experience with the following software a plus: Prism/GraphPad, FlowJo/Cytobank, Microsoft Word/Excel/Powerpoint, a plus: SnapGene, DOE Software/JMP.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and four years of related experience, or Master’s degree and two years of related experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent understanding of scientific principles
- Working experience with aseptic cell culture
- cGMP clean room experience
- Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications
- Ability to work independently, maintain relationships and provide ongoing reporting to functional management
- Excellent organizational skills and demonstrated ability to complete detailed work.
- frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.
*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- May require working in close proximity to blood borne pathogens.
- Ability to work under deadlines and meet/ exceed unpredictable manufacturing schedules.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
- Position requires working in a cGMP clean room environment.
- Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
- Position may work with human embryonic stem cells (hESCs).
- Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
- May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/ Chemicals, and confined spaces.
- May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu.
- Schedule: Full-time
- Job Code: 4934
- Employee Status: Regular
- Grade: J
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 86674