Manufacturing Technician

   MAXIM BIOMEDICAL

 Position Title 

Department



Manufacturing Technician

 

 

ManufacturingReports toGroup

 

Manufacturing Supervisor or designee  

 

Manufacturing Location Supervisory Responsibility

 

Rockville, MD – 1500 East Gude Dr.

 

None

 

Summary

 

 

Prepares Buffers and Reagents Manufacture Western Blot Strips

Produce Viral Antigens Manufacture EIA plates

Produce Recombinant Antigens  Filling and Labeling

Assembles Western Blot and EIA Kits

 Organizational Relationships 

Internal

 All Rockville Departments

External

 

Vendors, visitors, and external auditors

 

 

 Specific Duties and Responsibilities

 

· Prepares buffers, reagents, and kit bulk controls as scheduled following SOPs

· Manufacture polyacrylamide gels and coat microplates

· Add viral antigen to gels and electrophoreses for protein separation

· Transblot separated proteins from gels to nitrocellulose sheets

· Process and cut finished nitrocellulose sheets into test strips

· Produce viral antigens and recombinant proteins in cell culture facility

· Properly freeze and thaw cells

· Prepare media and buffer solutions

· Grow mammalian and insect cells

· Purify proteins

· Concentrate virus and inactivate virus

· Perform contamination testing, cell counts

· Aseptically fill components in class 100 clean room and nitrogen bubble using manual and automated equipment

· Operate automated EIA plate coating and heat sealing equipment

· Print labels and label components by hand and by using an automated label machine

· Assemble and inspect kits as schedule following SOPs

· Clean, calibrate, and maintain laboratory equipment

· Clean glassware, autoclave equipment and waste as necessary

· Properly package and dispose of hazardous waste

· Clean, calibrate, and maintain laboratory equipment

· Maintain accurate production documents, lab records, and log books

· Follow Good Manufacturing (GMP), Quality System Regulation (QSR), and safety regulations

· Assist Product Technology with validations

· Write and revise written procedures (Standard Operating Procedures (SOP), Manufacturing Procedures (MP)) as necessary

· Support kit assembly and packaging operations, as well as Gel production, when required

· Other duties as assigned

·  Required Knowledge, Skills and Abilities 

· BS/BA degree in the biosciences or related experience

· Ability to operate basic laboratory equipment

· Knowledge of basic laboratory techniques

· Knowledge of sterile filtration and aseptic technique

· Ability to work both independently and as part of a team

· Ability to organize and prioritize workload to meet production schedule

· Good oral, written, and laboratory math skills

· Working knowledge of QSRs and GMPs

 Working Conditions/Hazards

Work Hazards:





Not Applicable x  Applicable









 x  Mechanical  Bacteriological

 





 x Electrical Radiation

 





 x Viral  x  Weight

 



 x Chemical

 

Describe Items Checked:

 

Work involves operating electrical laboratory equipment from handheld mixers to autoclaves. Plasmas used to make controls are handled in accordance with blood borne pathogen protocols. Chemicals used for buffers and reagents are hazardous and are handled in accordance with Material Safety Data Sheets (MSDS). Must be able to lift lab equipment weighing up to 50 lbs.

Physical Demands:





Not Applicable x Applicable









10 lb. max x  standing

 





20 lb. max x  walking

 







 x  50 lb. max kneeling

 





100 lb. max climbing

 





over 100 lb. x  repetitive motions

Describe Items Checked:

 

Work involves movement from one task to another mostly in a standing position. Some tasks may require repetitive hand motions over a two-hour period.Human Resources Use Only

Salary Range

 

 

 

 



Approvals:

Superviosr

 

 

 

 

 

 

Employee

 

 

 

 

 

 Classification

 

 ExemptNon-Exempt