Director, Cyclotron and Radiochemistry Facility
Company: College of Charleston
Location: Palo Alto
Posted on: September 21, 2023
Job Description:
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, . The expected pay range for this position is
$144,000 to $165,000 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. As an organization that receives
federal funding, Stanford University has a COVID-19 vaccination
requirement that will apply to all university employees, including
those working remotely in the United States and applicable
subcontractors. To learn more about COVID policies and guidelines
for Stanford University Staff, please visit Additional Information
- Schedule: Full-time
- Job Code: 4935
- Employee Status: Regular
- Grade: L
- Requisition ID: 98543
- Work Arrangement : On Site
#J-18808-Ljbffr
Keywords: College of Charleston, Palo Alto , Director, Cyclotron and Radiochemistry Facility, Executive , Palo Alto, California
Didn't find what you're looking for? Search again!
Loading more jobs...