Validation Specialist

Radiology

Full Time

75246BR

Job Summary

The Validation Specialist will work together with the RPF managers and a cross-functional team in a fast-paced and dynamic work environment to plan, execute, and document validation experiments for the submission of a new drug application to the US FDA. 

The Validation Specialist will be responsible in all aspects of the validation of manufacturing processes, including writing standard operating procedures, performing validation experiments, equipment suitability tests, and managing raw material inventory.

Key responsibilities include:

• Develop and validate standard operating procedures (SOP) that are compliant to 21 CFR 212 for the manufacturing of positron emission tomography (PET) radiopharmaceuticals
  • Under minimal supervision from RPF managers, plan and perform validation and qualification experiment
  • Perform manufacturing and quality control test of PET radiopharmaceuticals
  • Gather, process data, and write validation reports
  • Raise and complete change control reports for newly developed SOP. Perform risk assessment on validated processes and changes
• Assist in the development of New Drug Application (NDA)
  • Assist in the writing the Chemistry, Manufacturing, and Controls (CMC) section

Assist in the developing response and perform experiments necessary for Information Requests (IR) by the FDA

• Independently set up, operate, and troubleshoot automated synthesis systems and quality control equipment like High-performance liquid chromatography (HPLC), Gas chromatography (GC), Radio thin layer chromatography (R-TLC), etc.
  • Develop and run system suitability test of manufacturing equipment
  • Responsible for the upkeep of daily and periodic maintenance of manufacturing equipment
  • Troubleshoot and repair manufacturing equipment
• Inventory control
  • Manage overall inventory related to the project
  • Responsible for vendor and raw material qualification
• Coordinate all activities related to NDA submission
  • Interface with external collaborators for successful process transfer

• Perform other project-relate duties and tasks as assigned.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up):TCS Non-Academic Titles Search (ucop.edu)

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% – 120% of the established mid-point. An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Department Description

The Department of Radiology & Biomedical Imaging is one of the largest departments in the School of Medicine at UCSF. Its mission is research (basic and clinical), teaching, patient care, and public service. The Department has 32 sections and research units, 132 full-time faculty, 45 other academic (research) appointees, 34 fellows, 51 residents, 40 post docs, and 16 graduate students across six sites: Parnassus, SFGH, VA Medical Center, Mt. Zion, China Basin Landing, and Mission Bay (QB3). Many of our faculty conduct research activities and manage large research staffs, including students, fellows, post docs, and staff research associates. Some conduct bench research in wet lab settings; others have dry lab (computer based) research programs or specialize in clinical research. The Cyclotron Facility is a specialized particle production service that allows clinicians and investigators to have access to locally produced radiopharmaceuticals.

Required Qualifications

• Bachelor’s degree in Chemistry or related area and or equivalent combination of education/experience
• Minimum one year of GMP or related experience
• Ability to work in a collaborative manner, to assist in identifying any challenges or barriers.
• Effective written and verbal communication skills.
• Organizational abilities and decision-making to prioritize work assignments.
• Working knowledge necessary to begin independent application of principles, practices and procedures in the completion of assignments.
• Working knowledge of engineering principles and methods in order to independently perform professional engineering design work of limited scope and complexity.
• Demonstrated excellent attendance and reliability
• Interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.
• Communication skills; includes verbal and written, active listening, and critical thinking skills. Clear and concise communicator.
• In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
• Ability to effectively meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

Preferred Qualifications

• Analytical chemistry experience (HPLC, GC, TLC)
• PET drug manufacturing / radiopharmaceutical production experience

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Job Code and Payroll Title

007119 RSCH AND DEV ENGR 2

Job Category

Professional (Non-Clinical), Radiology

Bargaining Unit

99 – Policy-Covered (No Bargaining Unit)

Additional Shift Details

M-F, 0800 – 1700; occasional weekend work