Job Description

POSITION OVERVIEW:

Primary responsibility of the incumbent will be the execution of standard operating procedures (SOPs) and batch records in the production of Flublok Drug Substance within the dedicated Cell Culture area (cell maintenance and virus stock generation) of the cGMP commercial manufacturing facility.

Duties will include executing techniques such as aseptic cell culture sampling and analysis, cell splitting for cell stock maintenance in flasks, preparation of virus stock in flasks and bioreactors, cell scale up to bioreactors for protein production, cleaning and preparation of workspaces and biosafety cabinets; setup and operation of 100L single-use bioreactor (SUB); scaleup cell culture and cell stock vial thaw, cleaning and maintenance of process equipment.

The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, shaker incubators, tabletop centrifuge and the 100L SUB. Aseptic sampling when required via the use of environmental monitoring equipment.

Secondary responsibilities will be to aid in troubleshooting of problems as they arise in the cell culture area. Business needs may also require cross training and operations in flex areas.

RESPONSIBILITIES:

• In depth understanding of techniques and processes being executed on routine basis.

• Responsible for all aspects of insect cell culture maintenance and scale-up, including cell splits in flasks, pooling cells to seed bioreactors, and thawing frozen cell vials to initiate new cell lines.

• Responsible for the generation of virus stock in flask(s) and 100L single-use bioreactor, including but not limited to the use of ancillary equipment dissolved oxygen probes, tube welder, tube sealer, peristaltic pumps, etc.

• Perform cell analysis and data interpretation of cell culture samples with the use of the cell counter, including operation of microscope for contamination checks.

• Interacts with other departmental personnel to assist in resolving manufacturing quality issues.

• Technician should have the ability to manage and analyze manufacturing data

• Ensure good documentation practices (GDP) in execution and reviews of production records.

• Responsible for all required cGMP training including additional training assigned by their manager.

• Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.

• Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.

• Work a flexible work schedule, weekends and holidays as required, and as needed by department.

• Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.

• Other duties as they are required.

REQUISITE EDUCATION/SKILLS:

• High School degree with at least 2 years of work experience, or training within a cGMP manufacturing environment

• General knowledge of cGMP, GDP, SOP’s

• English fluent, both written and spoken

• Good communication and social skills

• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required

Previously JP9785 REQUISITE EDUCATION/SKILLS: • High School degree with at least 2 years of work experience, or training within a cGMP manufacturing environment • General knowledge of cGMP, GDP, SOP’s • English fluent, both written and spoken • Good communication and social skills • Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required

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