Location: San Francisco, CA
Company: Legend Biotech
studies using QBD principles to develop a thorough understanding of operation performance parameters for T cell manufacturing process. Lead from the lab to advance novel and differentiated cell therapy products toward clinical milestones, by working collaboratively with internal cross-functional teams and external partners.
Evaluate, develop and implement functionally closed systems for T manufacturing process. Oversee development activities for platform production processes and ensure processes are suitable for early-stage c GMP clinical development. Identify and evaluate new technologies to improve manufacturing outcomes such as: reduce costs, throughput, and quality. Perform in-vitro
cellular assays involving flow cytometry, cytotoxicity, and functional characterization of genetically engineered primary T cells. Contribute to regulatory filings as needed for IIT and IND submissions.
Support the technology transfer of the manufacturing process within Legend as assigned. Accurately capture data in a timely manner, ensuring data integrity and protocol compliance. Requirements Ph D or MS in Biological Sciences or related fields with 3 to 6 + years of experience working within biologics process development; Previous experience and working knowledge of T-cells or immunological cell therapies. Experience with cell therapy manufacturing scale up, process development and process
optimization are required. Create methods to monitor cellular immunophenotypes engaged in selection, activation, transduction, expansion and cryopreservation Develop methods to understand cellular impurities and impacts of cellular expansion, formulations/cryopreservation Experience with functionally closed systems or early technology evaluations for large-scale autologous or allogenic CAR-T cells processing are highly desirable.
Experience with cell-based functional assays using engineered and/or primary human cells are preferred. Good working knowledge in c GMP manufacturing of biological process and ICH regulations #LI-RT1 #LI-Onsite #J-18808-Ljbffr
Biotech/pharmaceutical jobs encompass a broad range of careers within the life sciences industry, dedicated to developing drugs, vaccines, and therapies that improve human health. People in this field work in various settings including laboratories, manufacturing facilities, and corporate offices. These roles often require a blend of scientific expertise and regulatory knowledge, as professionals must adhere to strict standards while innovating. Characteristically, these jobs demand a commitment to rigorous research, attention to detail, and a passion for advancing medical science to meet patient needs. As this sector thrives on cutting-edge technology and scientific breakthroughs, professionals frequently engage in lifelong learning to keep pace with rapid advancements.
Biotech/Pharmaceutical jobs involve roles in the development, manufacturing, and commercialization of medicinal products and innovative therapies. These positions often require a strong foundation in life sciences, and employees work in various settings, including laboratories, manufacturing facilities, and corporate offices. Characterized by rigorous research and adherence to strict regulatory standards, this sector offers roles ranging from research scientists and clinical trial managers to quality assurance specialists and regulatory affairs coordinators. Employees in this field contribute to advancing medical science and improving patient healthcare, often engaging in cross-disciplinary collaboration and operating at the forefront of technology and innovation.
Biotech/pharmaceutical jobs are positions within the sector that focuses on applying biological and chemical principles to the development of drugs, therapies, and medical technologies. These roles often entail conducting research, developing new medications, ensuring quality control, and overseeing clinical trials. The field is characterized by its innovative nature, adherence to stringent regulatory standards, and its critical role in advancing healthcare and patient outcomes. Careers in this industry often require specialized education and training in fields like biology, chemistry, pharmacology, and can range from laboratory scientists to regulatory affairs managers.
and post-analytic procedures on biological specimens to ais health care providers in the diagnosis, treatment, monitoring and prevention of disease. Job Description: JOB ACCOUNTABILITIES: PRE-ANALYTIC, ANALYTIC AND POST-ANALYTIC WORK: Under direct supervision of a Clinical Lab Scientist (CLS), performs procedures to complete test order entry, specimen collection and specimen processing/handling.
--- Performs analyses of biological specimens using automated and manual test methods of waived or moderate complexity (per CLIA definition), producing test results necessary for the diagnosis, treatment, monitoring and prevention of disease. --- Performs post-analytic procedures, including interpretation,
releasing, reporting results; amending/correcting results, responding to inquiries, and specimen storage and retrieval. Recognizes when patient results require additional action prior to reporting (e.
g. delta checks and critical values), taking action appropriately. EQUIPMENT: Calibrates and adjusts laboratory equipment according to requirements and manufacturer's guidelines, including providing regular preventive maintenance (where automated methods are used) of analytical equipment and performing minor adjustments and repairs. QUALITY ASSURANCE: Scope of Quality Assurance (QA) duties and tasks includes maintaining a safe and orderly work area, inventory management, quality control,
proficiency testing, record keeping, privacy, security and confidentiality, and continual process improvement.
Recognizes when test systems are not functioning within control, taking action appropriately. JOB KNOWLEDGE & CRITICAL THINKING: Maintains up-to-date operational information and job knowledge; effectively applies information, job knowledge and critical thinking to make sound decisions and solve problems within scope of job responsibilities; escalates problems appropriately if outside of job scope. Completes competency backssment activities as assigned. CUSTOMER SUPPORT: Contributes to the satisfaction of internal and external customers by responding to and resolving - inquiries, complaints, and problems; or by escalating appropriately if problem is outside of job scope.
TRANSFUSION SERVICE: If assigned to the Transfusion Service, performs various duties under direct supervision of a CLS. --- Manages blood product inventory, maintaining adequate working and safety stock. --- Performs pre-analytic, analytic and post-analytic procedures for moderate complexity testing. --- Prepares and issues blood products for transfusion. COMPLIANCE: Adheres to applicable laws, regulations, codes, accreditation standards, policies, processes and procedures EDUCATION: -Associate's Degree CERTIFICATION & LICENSURE: MLT-Medical Laboratory Technician Upon Hire SKILLS AND KNOWLEDGE: Demonstrated knowledge and technical competence in routine specimen collection, preparation, testing applications, laboratory operations, and quality assurance in one or more assigned clinical specialty areas; examples: Chemistry, Special Chemistry, Hematology (no microscopy), Urinalysis (no microscopy) and Coagulation.
Quantity of Work: Ability to organize and prioritize job duties and assigned tasks for completion within expected time-frames Proficiency: Quality of Work: Ability to accurately, precisely, and reliably perform job duties and assigned tasks.
Demonstrates sound judgment and problem solving relevant to assigned duties. Proficiency: Culturally Competent Communication: Ability to compassionately and effectively interact with patients of diverse ages, backgrounds, values, beliefs and behaviors Proficiency: Workflow Management Ability to appropriately respond to: 1) fluctuations in volume; 2) unexpected situations or problems such as equipment or information systems failure; 3) shift-to-shift hand-offs; 4) STAT test orders; 5) specimen integrity issues 6) regular review of pending logs, priority assignments, etc.
Proficiency: Adherence to Practices and Procedures: Ability to follow standard practices, processes, and procedures in sequence. Knowledge of applicable local/state/federal regulations, codes, policies, and procedures aimed at ensuring the privacy and safety of patients. Ability to use computers, including Microsoft Office suite, electronic mail, internet, etc. -Job Shift: Days Schedule: Per Diem/Casual Shift Hours:8Days of the Week: Variable Weekend Requirements: As Needed Benefits: No Unions: No Position Status: Non-Exempt Weekly Hours:0Employee Status: Per Diem/Casual Number of Openings:1Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans.
Pay Range is $50.35 to $62.93 / hour The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs.
Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package. About Us Working at Sutter Health #J-18808-Ljbffr
