Radiopharmacist, Cyclotron and Radiochemistry Facility (on-site)

Stanford University is seeking a Radiopharmacist for the Cyclotron and Radiochemistry Facility (CRF) to lead quality assurance and quality control for PET radiopharmaceuticals manufactured under current Good Manufacturing Practice (cGMP) for clinical use and clinical trials. The Radiopharmacist is the CRF's primary point of contact with the FDA, responsible for all regulatory correspondence and for preparing for and managing on-site FDA inspections, and supervises the CRF Quality Assurance Analyst.

The primary purpose of the Radiopharmacist, Cyclotron and Radiochemistry Facility (CRF), is to support the CRF and be responsible for the management, prioritization, and resource allocation in order to maintain appropriate cGMP, GLP, quality control (QC) and quality assurances (QA) for all radiochemistry tracers produced on-site.

The Radiopharmacists will also share knowledge on the pharmaceutical aspects of patient care/clinical trials involving radiopharmaceuticals. This position will serve as consultant within the Department of Radiology, the RDRC, Institutional Compliance, industrial collaborators, and other departments on the design and implementation of various projects involving the use of radiopharmaceuticals.

The Radiopharmacist serves as the CRF's primary point of contact with the U.S. Food and Drug Administration (FDA), responsible for all regulatory correspondence and for leading preparation for and management of on-site FDA inspections. The position leads the CRF quality assurance function and supervises the QA Analyst.

DESIRED QUALIFICATIONS:

• Doctor of Pharmacy Degree (Pharm.D.) from an accredited pharmacy school.
• Minimum 4 years of experience in a clinical laboratory/research setting with demonstrated experience with radiopharmaceutical use.
• Knowledge of USP 797, USP 823, and USP 825.
• CA State Board of Pharmacy license.
• Board Certified Nuclear Pharmacist (BCNP) preferred.
• Direct experience hosting or supporting FDA inspections and preparing responses to FDA Form 483 observations. Working knowledge of 21 CFR Parts 211, 212, and 314.
• Experience with quality oversight of theranostic radiopharmaceutical manufacturing, including therapeutic radionuclides such as At-211, Ac-225, Pb-212, or Lu-177.

CERTIFICATIONS & LICENSES:

CA State Board of Pharmacy license

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 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 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.

ADDITIONAL DUTIES*:

• Serve as the primary point of contact with the FDA for all regulatory correspondence, and lead preparation for and management of on-site FDA inspections.
• • Other duties may also be assigned.

Core Duties:

• 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.

Minimum Education and Experience

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:

• 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

Core Duties:

• 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.

Minimum Education and Experience

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:

• 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