Stanford University is seeking a Director of the Cyclotron and Radiochemistry Facility (CRF), housed within the Department of Radiology at Stanford University. The CRF Director will lead the expansion of the program and work closely with the department leadership to commission the new facility. Lead translational development for novel radiopharmaceuticals for use in preclinical research, clinical trials, and clinical care; 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 radiopharmaceutical manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for diagnosing and staging patients with disease.
In addition, provide oversight of the preclinical and clinical production of all radioisotopes and radiopharmaceuticals produced within the CRF as directed by Current Good Manufacturing Practices (cGMP), internal Standard Operating Procedures (SOPs), and FDA regulations (21 CFR 212). The Director will manage the CRF staff and be responsible for the operational, budgetary, and programmatic needs of the CRF to meet the programmatic goals of the department.
Duties include:
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.
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.
Create new industry standards and best practices; direct and develop technical scientific elements of regulatory filings (i.e., chemistry, manufacturing and controls); develop and maintain relationships with vendors to evaluate devices, supplies and materials relevant to process development and manufacturing.
Author or co-author articles, presentations, or scientific papers for peer review journals and/or presentation at national/international scientific meetings/conferences. Write, submit and address reviewer comments related to novel methods in process development and manufacturing.
Identify research and development funding opportunities.
Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
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 safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.
- Other duties may also be assigned.
DESIRED QUALIFICATIONS:
PhD degree in a relevant scientific discipline, such as chemistry or chemical engineering.
7+ years of experience in the radiochemistry with a proven scientific track-record.
7+ years of experience with regulations of cGMP environment for radiopharmaceutical production and 21 CFR 212.
7+ years of QC/QA experience in the radiopharmaceutical industry.
Proven leadership skills to effectively lead and manage a cross-functional team in a fast-paced environment.
Strong attention to detail and experience with independently leading and managing multiple projects and priorities.
Experience working independently with academic and industry collaborators, managing budgets, SOW, and timelines.
Strong analytical, critical thinking, organization skills, and ability to effectively communicate with internal and external stakeholders at all levels.
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 chemistry, radiochemistry, and analytical quality control techniques.
Demonstrated project management experience.
Understanding of principles and compliance with cGMP, raw materials and documentation requirements.
Demonstrated cGMP radiochemistry production oversight and management.
PHYSICAL REQUIREMENTS*:
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 the job.
WORKING CONDITIONS:
May require working in close proximity to radioactive materials.
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 radiopharmaceutical production environment.
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 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.
The expected pay range for this position is $138,000 to $161,000 annually. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
Why work at Stanford?Stanford University has changed the world, over and over again.We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment. How will it change you?
