LAB RESEARCH ANALYST I
LAB RESEARCH ANALYST I
OCCUPATIONAL SUMMARY The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for early phase clinical trials as well as support pre-clinical development. In addition, this individual will be responsible for the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual will report to the Scientific/Research Lab Manager of the GMP Facility. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material fornovel cellular therapies.
Perform duties as dictated by standard operating procedures (SOPs) for cell manufacturing and under GXP (GLP, GTP, GMP) guidelines as directed.
Perform duties in a clean roomenvironment following GMP guidelines.
Operate instrumentation as needed for cell manufacturing such as cell seperators (Sepax), cell counters (Sysmex XS1000i orequivalent), Perform cell based assays (such as flow cytometry, colony forming unit assays) and otherassays (gram stain,endotoxin) to analyze, quality control and/or release a cellularproduct. Use aseptic technique to manufacture cell products forclinical trials.
Operate manual and automatic laboratory equipment to count cells; stain cells, wash cells, identify and quantify cell populations including stem cells
Perform environmental monitoring for the GMP laboratoryAssist in technology transfer of procedures from pre-clinical into GMP environment Write SOPs, and batch records as required.
Write validation plans and reports, stability plans and reports and study reports
Work with Lab manager and quality assurance to ensure the facility is in compliance for governing regulations. Participate in lab inspections and work with inspectors as needed
Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness,and timeliness as well as provide recommendations or conclusions as appropriate
Maintain sufficient inventory of supplies and reagents for performance of duties; clean and maintain laboratory equipment in good working order
Prepare and qualify reagents, stains, solutions, chemicals, and culture media as appropriate
Provide quality control testing, quality assurance data, safety andinfection control practices incompliance with internal and external regulations
Coordinate and participate in the preparation of antibodies, reagents,and solutions necessary for cell processing and testing
Maintain responsibility and confidentiality for patient identification,specimen labeling and specimen verification
Provide advanced problem solving, troubleshooting,interpretation/consultation, verification of specimen quality, and test results as needed
Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including standard precautions and hazardous chemical handling.Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
Assure remedial action is taken and documented whenever tests systems deviate from established performance specifications
Perform other related duties incidental to the work described herein.
Preferred qualifications: requires two years of laboratory experience, preferably in aGMP/regulated environment.
Skills: Good communication skills and the ability to work independently as well as part of team. Communicate and interact in a professional and courteous manner with co-workers, and others.
1888 LAB RESEARCH ANALYST I
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires a bachelor's degree in botany, biology, zoology or otherdirectly related scientific field.
Work requires two years of research experience. A related master'sdegree may offset required years of experience on a 1:1 basis, e.g., atwo year master's degree in lieu of two years of experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.