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PRODUCTION ASSOCIATE — CELLULAR PROCESSING

SCOPE:
Responsible for production of clinical and commercial products, including operating production equipment, manual operations, maintaining records and a clean room environment.

RESPONSIBILITIES:

Production Operations — Execute approved or draft 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.
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, write, review and revise Batch Records, SOPs, Item Specifications and PFDs necessary for the manufacture of product.
Personnel Training — Participate/assist with the training of new employees in accordance with company and governmental GMP regulations, policies and procedures. Provide oversight to temporary, part-time and/or contract personnel ensuring adherence to company procedures at all times. Ensure temporary, part-time and/or contract personnel are trained in accordance with company and governmental GMP regulations, policies and procedures. Ensure that all training documentation is current and complete.
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

QUALIFICATIONS:
• Requires a high school diploma with a minimum of 4-6 years laboratory experience, or Associate degree with 2-4 years experience. May have a Bachelors degree; however, not required.
• Basic aseptic technique required
• Experience with cell culture and cGMP preferred.
• Good interpersonal and communication skills (written and verbal) are required.
• Flexibility on work schedules and duties.

We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please a resume with a cover letter and salary history.

Argos Therapeutics is an Equal Opportunity Employer.