Stanford University is seeking a Clinical Manufacturing Quality Control Analytical Development Scientist 3 to develop and Qualify/Validate Analytical Methods for pre-clinical and clinical stage cell and gene therapy products. This role will be primarily responsible for developing and qualifying new analytical methods, writing and reviewing protocols and reports, creating new SOPs for the developed methods and training QC analysts for routine testing. This role will also be involved in assisting with investigations for adverse results and method remediation/improvement activities.
Develop, evaluate and perform complex chemical, biochemical, biological and/or microbiological testing, assays and procedures related to clinical materials manufactured at Laboratory for Cell and Gene Medicine (LCGM).
Participate and/or may lead a specific QC function in collaboration with clinical teams to evaluate, develop and design QC assays.
Collaborate with Process Development and Manufacturing and clinical teams in analytical development activities related to translational research.
Contribute as key subject matter expert for technology transfer, analytical methods, in process and /or release testing requirements, documentation and reporting for all QC related activities.
Participate in selection criteria and justification for QC raw materials; participate in inspection and testing of finished biologics products
Generate protocols and reports for new analytical methods for qualifications/verifications or validation
Participate in and/or may oversee and/or approve SOP development to ensure analytical methods execution is consistent with cGMP and documentation practices.
Troubleshoot to drive resolutions for equipment malfunctions and investigate out-of- specification and/or non-conforming test results.
Create training strategy and train QC Analysts on newly developed/qualified methods
Collaborate with facilities, operations, and quality assurance to oversee facility qualification and release activities.
May assist with reviewing IND submissions as an SME from QC
May need to assist with routine QC testing/Stability testing activities if required
* - Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and four years of related experience, or Master's degree and two years of related experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Applicable experience/expertise with one or more of the following QC Functions: QC Assay Development and validation/qualification, QC Routine Analytical Testing, QC Microbiology.
Applicable or related experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.
Experience leading people and/or technical projects.
Expert knowledge and understanding of cGMP requirements.
Excellent organizational skills and attention to detail.
CERTIFICATIONS & LICENSES:
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.
Additional PHYSICAL REQUIREMENTS: (remove if none)
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.
May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights
May require occasional local and overnight travel.
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.