Stanford University is seeking a Clinical Process Development & Manufacturing Professional 4 to lead translational development for novel cell-based therapy for use in clinical trials; provide highly specialized technical research, support and expert consultation including innovating and designing solutions for unique process development and product manufacturing activities related to clinical materials 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.
Provide leadership, scientific technical and subject matter expertise to oversee and manage process development and manufacturing activities including planning and implementation of major projects, clinical materials manufacturing activities, process development in translational medicine, services and facilities-related issues.
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.
Provide scientific leadership across all functional teams by overseeing and directing project development and management and budgeting oversight; collaborating and liaising with clinical investigators; consulting with and driving solutions for major projects with broad, significant clinical impact based on experience and subject matter expertise.
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.
Identify research and development funding opportunities.
May be asked to occasionally support clinical manufacturing efforts in the GMP clean rooms, and may have to complete required cGMP trainings
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
Master's degree in chemistry, microbiology, biological sciences, etc. with 4 years of experience. Or PhD 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 desired.
Experience with large scale/high throughput clinical cell manufacturing or gene-editing platforms a plus.
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 6 years relevant experience; or Master's degree and four years of related experience or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Thorough knowledge of the principles of molecular biology, biological process engineering
Demonstrated project management experience
Understanding of principles and compliance with cGMP, raw materials and documentation requirements
Demonstrated cGMP clean room oversight and management
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.
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.
WORK STANDARDS :
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.
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.