Process Development Scientist
The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Process Development Scientist (PDM3) to provide highly specialized technical research, support, and expert consultation including identifying, innovating, and designing solutions for unique process development activities. This includes process optimization and scale up of cell and gene therapies, testing novel gene editing technologies, and assessing the feasibility of new manufacturing/selection platforms for translation to clinical 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.
Process Development Duties include:
- Lead complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials. This includes testing and process optimization of closed-system cell manufacturing platforms and novel gene editing technologies. Mainly focused on CART and TCR based therapies.
- Coordinate PD activities with all necessary functional teams: operations, quality systems, regulatory affairs, and business & administration.
- Review standard operating procedures (SOPs), Batch Records, and documentation for tech transfer packages. 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.
- Identify strategies for innovation in production systems and manufacturing processes. Identify areas for culture optimization and common manufacturing deficiencies or gaps, to address with process improvements.
- Develop process development budget including sourcing, identifying and ensuring qualified and verified raw materials for scale up PD runs; outline overall and per/PD run costs for project materials and supplies and hours dedicated to complete all steps per PD run.
- Train and supervise Process Development 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.
- Participate in discussions with internal and external collaborators, providing analyzed data and review when appropriate.
- Author or co-author of abstracts for presentation at conferences or manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences.
- Perform detailed analysis of experiments and compilation of data using GraphPad/Prism, FlowJo/Cytobank, Excel, RStudio, etc.
- Develop methods for, perform, and supervise PD runs according to Biosafety Level 2 (BSL2) standards, with translation to cGMP-level clinical manufacturing requirements.
- Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
- May be asked to occasionally support clinical manufacturing efforts in the GMP clean rooms, and will have to complete required cGMP trainings
- May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- 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.
- Experience with CAR T, TCR, T cells, gene editing, and/or cell and gene therapy process development/manufacturing desired.
- Aseptic technique and cell culture experience is required
- cGMP experience is preferred.
- Management experience is preferred.
- Knowledge of and experience generating SOPs, batch records, and other documentation for tech transfer into cGMP preferred.
- Experience with tech transfer, engineering/qualification runs a plus.
- Experience with following assays required/preferred: cell culture, ELISA, tumor-killing assays, flow cytometry/CyTOF/FACS, qPCR/PCR, gene editing/CRISPR
- Experience with the following software preferred: Prism/GraphPad, FlowJo/Cytobank, Microsoft Word/Excel/Powerpoint, SnapGene, a plus: 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):
- Strong biological scientific background
- 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
- Ability to manage junior scientists
- 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 process development requirements and business needs. May be required to stay at work until product is harvested.
- 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: 86774