Per Diem Research Technologist

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The per diem Research Technologist will provide operational support to the Director of the Islet Isolation Specialized Service Facility (ISSF) at MGH, adhering to Standard Operating Procedures (SOPs) that apply to human islet manufacture preparation, manufacturing, conducting QC assays and laboratory operation. The Research Technologist will provide technical expertise to activities that pertain to human islet manufacturing processes and quality control assays.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Research Technologist will provide daily technical support for MGH Islet Isolation Specialized Service Facility (ISSF), and will perform the following tasks:

Human Islet Manufacturing Supporting Responsibilities:

(In conjunction with other team members or independently)

• Receive, inspect, document, collect COA or certificate of compliance/sterilization, and store supplies as indicated in SOPs

• Wash and sterilize of reusable items such as screens, gradient makers, marbles, digestion chamber, etc., as indicated in SOPs; Restock the supplies after each islet isolation

• Organize the facility's furniture, equipment, cabinet and shelves in a professional way; document all equipment maintenance log; Maintain all the incubators and waters bath as indicated in SOP; Remove waste and organize islet isolation facility after each isolation as indicated in SOPs

• Coordinate with the contractor who provides the monthly facility cleaning, documentation of the service work as indicated in SOPs: Perform the weekly clean room disinfecting procedure as indicated in SOPs

• Review the facility monitoring system on a daily basis and document any unusual activities based on SOP

• Assist with other duties, as required

Human Islet Manufacturing Responsibilities:

(In conjunction with other team members or independently)

• Work closely with team members in all activities that pertain to the human islet manufacturing processes required for clinical islet transplantation

• Set-up the laboratory for islet manufacturing as indicated in SOPs; Perform environmental monitoring (viable and non-viable); Clean hoods before, during and after the isolations as indicated in the SOP

• Prepare the solutions for islet isolation and handle the tissue as indicated in SOPs

• Deliver microbiology samples to the Microbiology Lab of MGH

• Prepare the FDA-PI, Dithionate dye before each isolation

• Culture and distribute tissue to investigator as indicated in SOPs

• Assist with other duties, as required

Quality Control Responsibilities:

• Treat INS, DNA and histology samples as indicated in SOPs; Label and store samples as indicated in SOPs

• Perform Glucose Stimulated Insulin Release as indicated in SOPs

• Perform INS quantification assay (ELISA) as indicated in SOPs

• Perform DNA quantification assay as indicated in SOPs

• Perform Endotoxin assay as indicated in SOPs

• Document and Update SOPs as needed

• Submit original test results to the Director of the ISSF

Data management Responsibilities:

• Ensure data from islet isolation and distribution are entered accurately into labs or CIT's database

• Ensure data quality integrity by quality-checking data entry of lower-level techs

• Generate reports for review by ISSF Director and PI's

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Technical skills include, but not limited to, human islet isolation, small and large animal surgery, PCR, electrophoreses, ELISA, histology, histochemistry, tissue/cell culture, and flow cytometry. Independently modifies techniques, as necessary.

• Other required abilities and competencies: 1) excellent verbal and written communication skills; 2) proficiency in Word, PowerPoint, Excel, and Internet searches; 3) self-motivated and able to work independently; 4) work carefully, safely and properly use protective equipment; 5) knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).

EDUCATION:

BS/BA in Biological Sciences, required. Candidates with a medical education background are preferred.

EXPERIENCE:

At least 3 years of directly related work experience required. GMP practice or lab managerial experience is preferred.

WORKING CONDITIONS:

Duties will be performed in both a specialized Islet Isolation cGMP facility and a standard research laboratory. This setting may create contact or exposure to one or more of the following: chemicals, fluids, sharp instruments and other supplies and equipment consistent with a research lab. Contact or exposure may be airborne or physical. Work will be conducted on a per diem basis with 1-2 weeks of advance notice, with work scheduling flexibility required. 25% to 40% of the time be outside the normal 9-5 schedule on the day of work.