MANUFACTURING ASSOCIATE Argos Therapeutics
ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include several Manufacturing Associates.
Argos Therapeutics, Inc. produces personalized dendritic cell therapies. For each patient, a therapy is created using the patient-s own biological samples. Manufacturing Associate positions are available for both Molecular Biology and Cellular Manufacturing. These Manufacturing Associates would be responsible for isolating and amplifying nucleic acids using PCR methods and other molecular biology techniques from each patient sample or processing white blood cell collections from each patient to isolate monocytes and culture these cells to generate the monocyte-derived dendritic cells. They would also be responsible for generating the key components for these personalized immunotherapies or the immunotherapeutic products for patients.
Responsible for manufacturing of clinical products, including operating manufacturing equipment, performing manual molecular biology or cellular manufacturing operations, maintaining GMP documentation, and maintain a clean room environment.
? Manufacturing Operations ? Execute approved procedures to manufacture product. Ensure that production batch records are completed at the highest standards according to company policies and procedures. Execute startup and specific process operations related to Argos product manufacturing. Perform daily manufacturing activities (process, equipment/component preparation and cleaning/sanitization of equipment and rooms) while ensuring adherence to company and governmental GMP regulations, policies and procedures. Assist Supervisor with technical review and implementation of new procedures. Ensure training is current for processes and procedures relevant to all manufacturing activities. In cooperation with others, assist in ordering supplies and maintaining an inventory adequate for production needs.
? Environmental Monitoring ? Execute and document environmental monitoring in classified areas as required.
? Documentation ? Ensure that all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations. As necessary, provide assistance with the review and revision of Batch Records, SOPs, Item Specifications and PFDs necessary for the manufacture of product.
? Personnel Training ? Assist with the training of new employees in accordance with company and governmental GMP regulations, policies and procedures. Assist with the oversight of temporary, part-time and/or contract personnel to ensure adherence to company procedures at all times. Ensure that all training documentation is current and complete. Ensure all qualifications required for GMP manufacturing are current.
? Validation ? Assist with executing validation protocols associated with manufacturing equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state.
? Confidentiality ? Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential information and handled appropriately as confidential information.
? Safety ? Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.
? Other duties as required.
? Requires an Associate degree with 0-2 years- experience. May have a Bachelors degree; however, not required.
? Basic aseptic technique required. Experience with PCR and other molecular biology techniques and/or cell culture required. Experience cGMP preferred.
? Good interpersonal and communication skills are required.
? Flexibility on work schedules and duties.
? Ability and willingness to be regularly, predictably and reliably at work.
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