Quality Control Analytical Development Scientist 3
Location: Stanford, California
Internal Number: 96004
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.
LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in early phase clinical trials.
LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. We invite you to join our team!
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
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.
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?