Senior Quality Control Analytical Scientist
Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Senior Quality Control Analytical Scientist to design, develop, evaluate and implement product characterization studies and quality control assays in consistent with principles of current Good Manufacturing Practice (cGMP). This Analytical Scientist role will focus on leading analytical and QC activities for a Phase III clinical production for Epidermolysis Bulosa.
LCGM is a cGMP 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 stage 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!
This is recruitment is for a 100% FTE fixed term position of up to 24 months.
• In collaborations to PIs and SMEs, the scientist will direct and oversee the creation of methods for the development of innovative biochemical or cell based assays related to quality control (QC) appropriate for a clinical phase III product . Develop, perform, document and report tests related to assays/analytical methods; including investigation and providing corrective action plan for out-of-specification and/or non-conforming test results.
• Write, review and edit accurate cGMP documents, including SOP, Test Proecedures, Sampling Plan, Certificate of Analysis and Qualification/Validation Protocols
• Key subject matter expert for protocol based assay qualification, validation and technology transfer. Planning and implementing critical analytical assessment of quality attributes to support the CMC development.
• Oversee product specific QC operation is performed in consistent to sampling plan and manufacturing schedules – including the operational assignments to individual QC associates for a variety of in process, drug substance, and drug product testings, sample shippments, data management and reporting data to stakeholders in a comprehensive manner.
• Work with SME to ensure the cGMP compliance of facility and environment for clinical production of products at different phases.
• Direct selection criteria and justification for QC raw materials;
• Direct staff on projects and investigations, prepare deviation reports for SOPs and test methods, and implement prevention or corrective actions
• Work with a cross-functional team to advance the development of projects.
* - Other duties may also be assigned
• Master’s degree or higher in relevant scientific deciplines with post-graduate work experience preferred
• Strong knowledge and experience in cell based analytical development, qualification and technology transfer
• Experience with cell and gene therapy analytical or process development
• Ability to effectively work in fast pace environment with cross functional groups
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree and eight years’ experience or advanced degree and five years’ experience in relevant scientific relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, and Engineering).
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity
• Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
• Expert knowledge and understanding of cGMP requirements.
• Extensive experience in QC innovation and analytical methods and validation tests development.
• Experience with technology transfer methods.
• Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.
• Experience leading and/or managing technical professionals.
• Demonstrated resolution of complex issues in creative and effective ways
• 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.
• 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 be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights
• May require extended or unusual work hours (including weekends) based on business needs.