The Laboratory for Cell and Gene Medicine is seeking a Director of Process Development and Manufacturing to provide strategic leadership, direction and technical expertise for the Center for Definitive and Curative Medicine (CDCM) programs including complex scientific, engineering and translational research that bring cell and gene therapy products from the bench to the bedside. This role leads and advises on best strategies to translate scientific discoveries from a research lab to a clinical grade lab, and on best approaches to develop and manufacture drug products according to current Good Manufacturing Practice (cGMP) and the highest regulatory standards. This Director is instrumental in implementing strategic vision for the LCGM to develop multiple technology platforms (including T cells, gene editing, pluripotent stem cells and vectors) to benefit Stanford faculty and research programs and will exercise delegated authority for policy and programmatic decisions and achieve goals through technical and managerial staff engaged in developing, advancing and applying science, engineering and technology.
The Laboratory for Cell and Gene Medicine (LCGM) is a multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.
Knowledge of: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements
Extensive experience in cellular immunology, stem cell biology, cellular therapies, and molecular biology.
Experienced in the culture and expansion of human blood cells, mechanical isolation and analysis of cell populations, bioreactor-based growth of human blood cells, cytokine biology, molecular biology, tissue engineering.
Software
- Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous device control software
- Statistical analysis software (Graph Pad Prism, SAS, etc)
- Flow Cytometry, Chromatography, Biorector control and analytical packages.
Machines/Equip: Req./Pref
- Bioreactors, FPLC, cell counter, magnetic selection devices, discreet particle counter, centrifuges, microscopes, pH meter, Flow cytometer, biosafety cabinet, plate readers, ultrafiltration devices.
Duties include:
- Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
- Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
- Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
- Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
- Develop policies and procedures as they relate to academic or program activities.
- Implement, evaluate and maintain quality control standards to ensure program success.
- Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
- Recommend the adoption of emerging technologies and the development of new methods and approaches.
- Negotiate with internal departments and external agencies with authority to commit resources and effort.
- Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- 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.
- 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.
Learn more about our team here: https://med.stanford.edu/lcgm.html
* - Other duties may also be assigned
DESIRED QUALIFICATIONS:
- PhD in microbiology, biological sciences, etc with an emphasis on cell and gene therapy.
- Experience with TCR, T cells, HSCs, iPSC, gene editing, and/or cell and gene therapy process development/manufacturing 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 in GMP manufacturing setting, technology transfer (e.g., from academic institutions or to a third-party contract manufacturing organization (CMO) and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP)
- 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
- Extensive experience in cellular immunology, stem cell biology, cellular therapies, and molecular biology.
- Experience in the culture and expansion of human blood cells, mechanical isolation and analysis of cell populations, bioreactor-based growth of human blood cells, cytokine biology, molecular biology, tissue engineering.
- Experience with bioreactors, FPLC, cell counter, magnetic selection devices, discreet particle counter, centrifuges, microscopes, pH meter, Flow cytometer, biosafety cabinet, plate readers, ultrafiltration devices.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience leading, managing, motivating and developing technical staff.
- Experience leading complex scientific, engineering or technical research projects or programs.
- Detailed understanding of relevant business and technical knowledge and problem resolution.
- Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
- Knowledge of emerging technologies, trends, methodologies, and resource management principles.
- Demonstrated ability to work and communicate effectively with others.
- Exceptional customer relationship and consensus building skills.
- Ability to influence and establish effective working relationships in a diverse environment.
- Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.
- Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), FACT and other regulatory requirements
CERTIFICATIONS & LICENSES:
None
PHYSICAL REQUIREMENTS*:
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally sit, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - 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.
Additional PHYSICAL REQUIREMENTS:
WORKING CONDITIONS:
May require extended hours, evenings and weekends.
