The Bone Marrow Treatment Cell Therapy Facility (BMT CTF) at Stanford University, Division of Blood and Marrow Transplantation, is seeking a Manufacturing Manager (Stanford series: Research Technical Manger 1). The BMT CTF is a multi-product 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 clinical trials and standard of care therapies. This manager will oversee a team of Manufacturing Specialists who will perform cell therapy processing, typically as operators, for a variety of cell therapies in cancer immunotherapy and stem cell regenerative medicine to support Investigational New Drug (IND) Phase I trials. This role works both independently and collaboratively across different functional areas: Process Development & Manufacturing, Regulatory Affairs, Quality Systems, Operations and Finance & Administration. Opportunities for Process Development will be available to incumbents in this position based on operational needs and current projects.
This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
Make decisions independently regarding projects, programs, and initiatives within confines established by management.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced technical and professional knowledge.
Monitor and evaluate completion of tasks and projects. Oversee interdepartmental activities and efforts.
Manage project budgets, schedules, and resources; lead planning activities for assigned area.
Oversee preparation of periodic financial and technical reports and operating plans.
Interface with customers to determine project requirements.
Select, develop, and evaluate personnel to ensure the efficient operation of the function.
Supervise other staff, including hiring, performance management, and related duties, in addition to instruction on complex techniques and direction on projects.
* - Other duties may also be assigned. EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing technical staff.
Demonstrated experience leading complex technical or engineering cell therapy projects or programs.
Demonstrated ability to work and communicate effectively with others.
Understanding of relevant business and technical knowledge and problem resolution.
Ability to articulate technical methodologies, specifications, and information.
Good customer relationship and consensus building skills
Ability to influence and establish effective working relationships in a diverse environment.
Experience working in a GMP environment in the cell therapy industry.
Demonstrated technical expertise and experience working with clients, developing CTP processes, technology transfer and project management.
Ability to resolve complex issues and make decisions, or encourage others to do so as appropriate, in a collaborative culture.
CERTIFICATIONS & LICENSES:
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:
Might require work in ISO-8 clean room for multiple hours depending on needs and demands of project and product being manufactured.
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.
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 require extended or unusual work hours based on research requirements and business needs.
Additional WORKING CONDITIONS:
May work with viruses and viral vectors: for example, lentiviruses, adeno-associated viruses, retroviruses.
May work with human embryonic stem cells (hESCs).
Complete Training for working in manufacturing clean rooms.
May work long hours during manufacturing and product release (which may include weekend work for manufacturing and product release); required to stay until product is released.
Complete all required training for the facility and for each project related to safety, quality, regulatory and operations.
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 based 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.
Job Family: Research Job Series: Research Technical Manager Job Code: 4986 Grade: K Exemption: Exempt Schedule: Full-time
Location: School of Medicine, 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.